US11076787B2 - Fluid control devices and methods of using the same - Google Patents

Fluid control devices and methods of using the same Download PDF

Info

Publication number
US11076787B2
US11076787B2 US16/129,066 US201816129066A US11076787B2 US 11076787 B2 US11076787 B2 US 11076787B2 US 201816129066 A US201816129066 A US 201816129066A US 11076787 B2 US11076787 B2 US 11076787B2
Authority
US
United States
Prior art keywords
fluid
actuator
housing
bodily fluid
control device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active, expires
Application number
US16/129,066
Other languages
English (en)
Other versions
US20190076074A1 (en
Inventor
Gregory J. Bullington
Jay M. Miazga
Shan E. Gaw
Timothy F. RAMSEY
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Magnolia Medical Technologies Ltd
Original Assignee
Magnolia Medical Technologies Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=65630000&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US11076787(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to US16/129,066 priority Critical patent/US11076787B2/en
Application filed by Magnolia Medical Technologies Ltd filed Critical Magnolia Medical Technologies Ltd
Publication of US20190076074A1 publication Critical patent/US20190076074A1/en
Assigned to Magnolia Medical Technologies, Inc. reassignment Magnolia Medical Technologies, Inc. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GAW, SHAN E., BULLINGTON, GREGORY J., MIAZGA, JAY M., RAMSEY, Timothy F.
Assigned to FISH & RICHARDSON P.C. reassignment FISH & RICHARDSON P.C. LIEN (SEE DOCUMENT FOR DETAILS). Assignors: Magnolia Medical Technologies, Inc.
Priority to US17/390,249 priority patent/US20220175284A1/en
Application granted granted Critical
Publication of US11076787B2 publication Critical patent/US11076787B2/en
Assigned to Magnolia Medical Technologies, Inc reassignment Magnolia Medical Technologies, Inc RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: FISH & RICHARDSON PC
Priority to US17/883,339 priority patent/US11529081B2/en
Priority to US17/883,340 priority patent/US11653863B2/en
Priority to US18/130,207 priority patent/US11903709B2/en
Priority to US18/299,680 priority patent/US11903710B2/en
Assigned to SYMBIOTIC CAPITAL AGENCY LLC, AS ADMINISTRATIVE AGENT reassignment SYMBIOTIC CAPITAL AGENCY LLC, AS ADMINISTRATIVE AGENT PATENT SECURITY AGREEMENT Assignors: Magnolia Medical Technologies, Inc.
Priority to US18/407,010 priority patent/US20240138734A1/en
Priority to US18/680,377 priority patent/US20240315622A1/en
Priority to US18/680,331 priority patent/US20240315620A1/en
Priority to US18/680,439 priority patent/US20240315623A1/en
Priority to US18/680,466 priority patent/US20240315624A1/en
Priority to US18/680,348 priority patent/US20240315621A1/en
Active legal-status Critical Current
Adjusted expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150946—Means for varying, regulating, indicating or limiting the speed or time of blood collection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150213—Venting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150229—Pumps for assisting the blood sampling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150251—Collection chamber divided into at least two compartments, e.g. for division of samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150992—Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B01L2200/027—Fluid interfacing between devices or objects, e.g. connectors, inlet details for microfluidic devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0684—Venting, avoiding backpressure, avoid gas bubbles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0689—Sealing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/141—Preventing contamination, tampering
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/14—Means for pressure control
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0478—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure pistons
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0487—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure fluid pressure, pneumatics

Definitions

  • the invention relates generally to the parenteral procurement of bodily fluid samples, and more particularly to fluid diversion, sequestration, and/or isolation devices and methods for procuring bodily fluid samples with reduced contaminants such as dermally residing microbes and/or other contaminants exterior to the bodily fluid source.
  • Health care practitioners routinely perform various types of microbial as well as other broad diagnostic tests on patients using parenterally obtained bodily fluids. As advanced diagnostic technologies evolve and improve, the speed, accuracy (both sensitivity and specificity), and value of information that can be provided to clinicians continues to improve. Maintaining the integrity of the bodily fluid sample during and/or after collection also ensures that analytical diagnostic results are representative of the in vivo conditions of a patient.
  • diagnostic technologies that are reliant on high quality, non-contaminated, and/or unadulterated bodily fluid samples include but are not limited to microbial detection, molecular diagnostics, genetic sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next-generation sequencing (NGS), etc.), biomarker identification, and the like.
  • genetic sequencing e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next-generation sequencing (NGS), etc.
  • biomarker identification e.g., microbial detection, molecular diagnostics, genetic sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next-generation sequencing (NGS), etc.), biomarker identification, and the like.
  • DNA deoxyribonucleic acid
  • RNA ribonucleic acid
  • NGS next-generation sequencing
  • resultant analytical test results may be inaccurate, distorted, adulterated, falsely positive, falsely negative, and/or otherwise not representative of the actual condition of the patient, which in turn, can inform faulty, inaccurate, confused, unsure, low-confidence, and/or otherwise undesired clinical decision making.
  • patient samples e.g., bodily fluids
  • microbial testing may include incubating patient samples in one or more sterile and/or non-sterile vessels that may contain culture media, common additives, and/or other types of solutions that are conducive to microbial growth.
  • the sample in the vessel may be analyzed directly (i.e., not incubated) and may not contain culture media or additives associated with incubating the specimen.
  • various technologies can be employed to assist in the detection of the presence of microbes as well as other types of biological matter, specific types of cells, biomarkers, proteins, antigens, enzymes, blood components, and/or the like during diagnostic testing.
  • examples include but are not limited to molecular polymerase chain reaction (PCR), magnetic resonance and other magnetic analytical platforms, automated microscopy, spatial clone isolation, flow cytometry, whole blood (“culture free”) specimen analysis (e.g. NGS) and associated technologies, morphokinetic cellular analysis, and/or other common or evolving and advanced technologies utilized in the clinical laboratory environment to characterize patient specimens and/or to detect, identify, type, categorize, and/or characterize specific organisms, antibiotic susceptibilities, and/or the like.
  • PCR molecular polymerase chain reaction
  • magnetic resonance and other magnetic analytical platforms include automated microscopy, spatial clone isolation, flow cytometry, whole blood (“culture free”) specimen analysis (e.g. NGS) and associated technologies, morphokinetic cellular analysis, and
  • the detection of the presence of microbes includes allowing the microbes and/or organisms to grow for an amount of time (e.g., a variable amount of time from less than an hour to a few hours to several days—which can be longer or shorter depending on the diagnostic technology employed).
  • the microbe and/or organism growth can then be detected by automated, continuous monitoring, and/or other methods specific to the analytical platform and technology used for detection, identification, and/or the like.
  • microbes In culture testing, for example, when microbes are present in the patient sample, the microbes flourish over time in the culture medium and, in some instances, automated monitoring technologies can detect carbon dioxide produced by organism growth.
  • the presence of microbes in the culture medium suggests the presence of the same microbes in the patient sample which, in turn, suggests the presence of the same microbes in the bodily fluid of the patient from whom the sample was obtained.
  • the patient may be diagnosed and prescribed one or more antibiotics or other treatments specifically designed to treat or otherwise remove the undesired microbes from the patient.
  • microbes from a bodily surface e.g., dermally residing microbes
  • a lumen-containing device such as a peripheral IV catheter (PIV), a central line (PICC) and/or other indwelling catheter(s), collection with a syringe or any other suitable means employed to collect a patient specimen
  • PIV peripheral IV catheter
  • PICC central line
  • syringe any other suitable means employed to collect a patient specimen
  • tissue fragments, hair follicles, sweat glands, and other skin adnexal structures can be subsequently transferred to a culture medium, test vial, or other suitable specimen collection or transfer vessel with the patient sample and/or included in the specimen that is to be analyzed for non-culture based testing.
  • Another possible source of contamination is from the person drawing the patient sample (e.g., a doctor, phlebotomist, nurse, technician, etc.).
  • equipment, supplies, and/or devices used during a patient sample procurement process often include multiple fluidic interfaces (by way of example, but not limited to, patient to needle, needle to transfer adapter, transfer adapter to sample vessel, catheter hub to syringe, syringe to transfer adapter, needle/tubing to sample vessels, and/or any other fluidic interface or any combination thereof) that can each introduce points of potential contamination.
  • such contaminants may thrive in a culture medium and/or may be identified by another non-culture based diagnostic technology and eventually may yield a false positive and/or a false negative microbial test result, which may inaccurately reflect the presence or lack of such microbes within the patient (i.e., in vivo).
  • devices and/or systems can be used to reduce the likelihood of contamination, adulteration, and/or the like of bodily fluid samples for testing.
  • some known devices can be configured to collect, divert, separate, and/or isolate or sequester an initial volume of bodily fluid that may be more likely to contain contaminants such as dermally residing microbes or the like.
  • Some such devices can be cumbersome, non-intuitive, perceived as difficult to use, inappropriate or unusable as intended for the target patient population, etc.
  • some such devices can require training, user observation, intervention by more than one user, and/or can otherwise present challenges that can lead to limited efficacy based on variables including environmental, educational, clinician skill, patient condition, and/or the like. In some instances, such challenges can complicate the collection of consistently high quality samples that are non-contaminated, sterile, unadulterated, etc., which in turn, can impact the validity of test result outcomes.
  • some known passive diversion devices and/or systems may fail to adequately divert, sequester, and/or isolate a clinically desired and efficacious pre-sample volume of bodily fluid due to clinical realities such as, for example, the time required to fill a sequestration reservoir with a meaningful volume of fluid.
  • the operation of some known passive devices is dependent on a positive pressure applied by a bodily fluid source (e.g., a patient's blood pressure).
  • the positive pressure applied by the bodily fluid source may be insufficient to result in flow dynamics and/or flow rates that makes use of such devices practical in various clinical settings (including emergency rooms and other intensive settings).
  • the patient population with symptoms requiring diagnostic testing noted above commonly are in such physical condition that attaining vascular access and/or collection of bodily fluid samples can be difficult due to a hypotensive state (i.e., low blood pressure), hypovolemic state (i.e., low blood volume), and/or other physical challenges (e.g., severe dehydration, obesity, difficult and/or inaccessible vasculature, etc.).
  • Such states or physical conditions can result in difficulty in providing sufficient blood flow and/or pressure to achieve passive filling of a sequestration chamber, channel, reservoir, container (or other diversion volume) consistently with sufficient volume to meet clinically validated, evidence-based efficacy and results in diverting, sequestering, and/or isolating contaminants which otherwise can lead to distorted, inaccurate, falsely positive, falsely negative, and/or otherwise adulterated diagnostic test results.
  • Some such devices and methods can include, for example, bodily fluid collection with the assistance of various sources of external energy and/or negative pressure.
  • a system includes a housing, a flow controller, and a fluid collection device.
  • the housing has an inlet and an outlet, and forms a sequestration portion.
  • the inlet is configured to be placed in fluid communication with a bodily fluid source.
  • the sequestration portion is configured to receive an initial volume of bodily fluid from the bodily fluid source.
  • the flow controller is at least partially disposed in the sequestration portion of the housing and is configured to transition from a first state to a second state.
  • the fluid collection device is configured to be fluidically coupled to the outlet to produce a negative pressure differential within at least a portion of the housing. The negative pressure differential is operable to draw the initial volume of bodily fluid into the sequestration portion when the flow controller is in the first state and is operable to draw the sample volume of bodily fluid through the outlet and into the fluid collection device when the flow controller is in the second state.
  • FIG. 1 is a schematic illustration of a fluid control device according to an embodiment.
  • FIGS. 2-5 are various views of a fluid control device according to an embodiment.
  • FIGS. 6-8 are various views of a fluid control device according to an embodiment.
  • FIGS. 9 and 10 are front view illustrations of a fluid control device in a first operating mode and a second operating mode, respectively, according to an embodiment.
  • FIGS. 11 and 12 are front view illustrations of a fluid control device in a first operating mode and a second operating mode, respectively, according to an embodiment.
  • FIGS. 13-15B are various views of a fluid control device according to an embodiment.
  • FIGS. 16-18 are various views of a fluid control device according to an embodiment.
  • FIGS. 19-25 are various views of a fluid control device according to an embodiment.
  • FIGS. 26-28 are each a perspective view of a fluid control device according to different embodiments.
  • FIGS. 29-34 are various views of a fluid control device according to an embodiment.
  • FIGS. 35-40 are various views of a fluid control device according to an embodiment.
  • FIGS. 41-44 are various views of a fluid control device according to an embodiment.
  • FIGS. 45-50 are various views of a fluid control device according to an embodiment.
  • FIGS. 51 and 52 are cross-sectional views of a fluid control device according to an embodiment.
  • FIG. 53 is a flowchart illustrating a method of using a fluid control device according to an embodiment.
  • a first reservoir, channel, flow path, or portion of the device can receive an initial amount of the bodily fluid flow, which then can be substantially or fully sequestered (e.g., contained or retained, circumvented, isolated, segregated, vapor-locked, separated, and/or the like) in or by the first reservoir or first portion of the device.
  • contaminants such as dermally residing microbes or the like can be included and/or entrained in the initial amount of the bodily fluid and likewise are sequestered in or by the first reservoir or first portion of the device.
  • any subsequent amount of the bodily fluid flow can be diverted, channeled, directed, flow controlled (e.g., manually, automatically, and/or semi-automatically) to a second reservoir, second portion of the device, and/or any additional flow path(s).
  • any additional and/or subsequent amount(s) of bodily fluid flow are substantially free from contaminants that may otherwise produce inaccurate, distorted, adulterated, falsely positive, falsely negative, etc., results in some diagnostics and/or testing.
  • the initial amount of bodily fluid also can be used, for example, in other testing such as those less affected by the presence of contaminants, can be discarded as a waste volume, can be infused back into the patient, and/or can be used for any other suitable clinical application.
  • a feature of the fluid control devices and/or methods described herein is the use of an external negative pressure source (e.g., provided by a fluid collection device or any other suitable means) to (1) overcome physical patient challenges which can limit and/or prevent a sufficient pressure differential (e.g., a differential in blood pressure to ambient air pressure) to fully engage the sequestration chamber and/or to transition fluid flow to the fluid collection device; (2) result in proper filling of the sequestration chamber with a clinically validated and/or desirable volume of bodily fluid; (3) result in efficient, timely, and/or user-accepted consistency with bodily fluid collection process; and/or (4) provide a means of manipulating and/or automatically transitioning fluid flow (e.g., movement of physical components of the system or changing, switching, engaging, and/or otherwise employing or achieving desired fluid flow dynamics) to enable sequestration and/or isolation of the initial sample and collection of a subsequent sample.
  • an external negative pressure source e.g., provided by a fluid collection device or any other suitable means
  • a fluid control device includes an inlet and an outlet.
  • the inlet is configured to be placed in fluid communication with a bodily fluid source or an intermediary bodily fluid transfer device and the outlet is configured to be placed in fluid communication with a fluid collection device such as, for example, a sample reservoir, a syringe, a lumen-containing device, and/or any other suitable bodily fluid collection and/or transfer device.
  • the fluid control device has a first state in which a negative pressure differential produced from an external source (e.g., the fluid collection device such as a sample reservoir, a syringe, a vessel, and/or any suitable intermediary fluid reservoir) is applied to the fluid control device to draw an initial volume of bodily fluid from the bodily fluid source, through the inlet, and into a sequestration and/or diversion portion of the fluid control device (which can be formed by or in the fluid control device or coupled thereto).
  • the fluid control device has a second state in which (1) the sequestration chamber sequesters the initial volume, and (2) the negative pressure differential draws a subsequent volume of bodily fluid, being substantially free of contaminants, from the bodily fluid source, through the fluid control device, and into the fluid collection device.
  • a system in some embodiments, includes a housing, a flow controller, and a fluid collection device.
  • the housing has an inlet and an outlet, and forms a sequestration portion.
  • the inlet is configured to be placed in fluid communication with a bodily fluid source.
  • the sequestration portion is configured to receive an initial volume of bodily fluid from the bodily fluid source.
  • the flow controller is at least partially disposed in the sequestration portion of the housing and is configured to transition from a first state to a second state.
  • the fluid collection device is configured to be fluidically coupled to the outlet to produce a negative pressure differential within at least a portion of the housing. The negative pressure differential is operable to draw the initial volume of bodily fluid into the sequestration portion when the flow controller is in the first state and is operable to draw the sample volume of bodily fluid through the outlet and into the fluid collection device when the flow controller is in the second state.
  • an apparatus in some embodiments, includes a housing and an actuator coupled to the housing.
  • the housing has an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured be placed in fluid communication with a fluid collection device.
  • the housing forms a sequestration portion that is configured to receive an initial volume of bodily fluid from the bodily fluid source.
  • the actuator has a first configuration in which a first fluid flow path places the inlet in fluid communication with the sequestration portion and a second configuration in which a second fluid flow path places the inlet in fluid communication with the outlet.
  • the fluid collection device is configured to be placed in fluid communication with the outlet to produce a negative pressure differential (1) within the first fluid flow path that is operable to draw the initial volume of bodily fluid into the sequestration portion when the actuator is in the first configuration, and (2) within the second fluid flow path that is operable to draw a sample volume of bodily fluid into the fluid collection device when the actuator is in the second configuration.
  • a method of using a fluid control device to obtain a bodily fluid sample with reduced contamination includes establishing fluid communication between a bodily fluid source and an inlet of the fluid control device.
  • a fluid collection device is coupled to an outlet of the fluid control device and is configured to produce a negative pressure differential within at least a portion of the fluid control device.
  • An initial volume of bodily fluid is received from the inlet and into a sequestration portion of the fluid control device in response to the negative pressure differential.
  • a flow controller disposed in the sequestration portion is transitioned from a first state in which the flow controller allows a flow of a gas through the flow controller and prevents a flow of bodily fluid through the flow controller, to a second state in which the flow controller prevents a flow of gas and bodily fluid through the flow controller.
  • the initial volume of bodily fluid is sequestered in the sequestration portion after the flow controller is transitioned to the second state and a subsequent volume of bodily fluid is transferred from the inlet to an outlet in fluid communication with a fluid collection device.
  • a member is intended to mean a single member or a combination of members
  • a material is intended to mean one or more materials, or a combination thereof.
  • the terms “about,” “approximate,” and/or “substantially” when used in connection with stated value and/or other geometric relationships is intended to convey that the structure so defined is nominally the value stated and/or the geometric relationship described.
  • the terms “about,” “approximately,” and/or “substantially” can generally mean and/or can generally contemplate plus or minus 10% of the value or relationship stated. For example, about 0.01 would include 0.009 and 0.011, about 0.5 would include 0.45 and 0.55, about 10 would include 9 to 11, and about 1000 would include 900 to 1100.
  • “bodily fluid” can include any fluid obtained directly or indirectly from a body of a patient.
  • “bodily fluid” includes, but is not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous, air, and the like, or any combination thereof.
  • proximal and distal refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient.
  • distal end the end of a device first touching the body of the patient
  • opposite end of the device e.g., the end of the device being manipulated by the user
  • any of the devices and methods can be used to procure bodily fluid samples with reduced contamination by, for example, diverting a “pre-sample” volume of bodily fluid prior to collecting a “sample” volume of bodily fluid.
  • pre-sample can be used interchangeably to describe and/or refer to an amount, portion, or volume of bodily fluid that is transferred, diverted, and/or sequestered prior to procuring the “sample” volume.
  • the terms “pre-sample,” “first,” and/or “initial” can refer to a predetermined, defined, desired, or given volume, portion, or amount of bodily fluid.
  • a predetermined and/or desired pre-sample volume of bodily fluid can be about 0.1 milliliter (mL), about 0.2 mL, about 0.3 mL, about 0.4 mL, about 0.5 mL, about 1.0 mL, about 2.0 mL, about 3.0 mL, about 4.0 mL, about 5.0 mL, about 10.0 mL, about 20 mL, about 50 mL, and/or any volume or fraction of a volume therebetween.
  • the pre-sample volume can be greater than 50 mL or less than 0.1 mL.
  • a predetermined and/or desired pre-sample volume can be between about 0.1 mL and about 5.0 mL.
  • the pre-sample volume can be, for example, a drop of bodily fluid, a few drops of bodily fluid, a combined volume of any number of lumen that form, for example, a flow path (or portion thereof) from the bodily fluid source to an initial collection chamber, portion, reservoir, etc. (e.g., a sequestration chamber).
  • sample when used in the context of a volume of bodily fluid can refer to a volume, portion, or amount of bodily fluid that is either a random volume or a predetermined or desired volume of bodily fluid collected after transferring, diverting, sequestering, and/or isolating the pre-sample volume of bodily fluid.
  • a desired sample volume of bodily fluid can be about 10 mL to about 60 mL.
  • a desired sample volume of bodily fluid can be less than 10 mL or greater than 60 mL.
  • a sample volume can be at least partially based on one or more tests, assays, analyses, and/or processes to be performed on the sample volume.
  • a fluid collection device can include, but is not limited to, any suitable vessel, container, reservoir, bottle, adapter, dish, vial, syringe, device, diagnostic and/or testing machine, and/or the like.
  • any of the embodiments and/or methods described herein can be used to transfer a sample volume into a sample reservoir such as any of those described in detail in U.S. Pat. No. 8,197,420 entitled, “Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination,” filed Dec. 13, 2007 (“the '420 patent”), the disclosure of which is incorporated herein by reference in its entirety.
  • a sample reservoir can be a sample or culture bottle such as, for example, an aerobic culture bottle or an anaerobic culture bottle.
  • the culture bottle can receive a bodily fluid sample, which can then be tested (e.g., via in vitro diagnostic (IVD) tests, and/or any other suitable test) for the presence of, for example, Gram-Positive bacteria, Gram-Negative bacteria, yeast, fungi, and/or any other organism.
  • IVD in vitro diagnostic
  • the culture bottle can receive a bodily fluid sample and the culture medium (disposed therein) can be tested for the presence of any suitable organism.
  • the culture medium can be subsequently tested using a PCR-based system to identify a specific organism.
  • diverting a pre-sample or initial volume of bodily fluid can reduce and/or substantially eliminate contaminants in the bodily fluid sample that may otherwise lead to inaccurate test results.
  • sample containers, reservoirs, bottles, dishes, vials, etc., described herein can be devoid of contents prior to receiving a sample volume of bodily fluid or can include, for example, any suitable additive, culture medium, substances, enzymes, oils, fluids, and/or the like.
  • a sample reservoir can include an aerobic or anaerobic culture medium (e.g., a nutrient rich and/or environmentally controlled medium to promote growth, and/or other suitable medium(s)), which occupies at least a portion of the inner volume defined by the sample reservoir.
  • a sample reservoir can include, for example, any suitable additive or the like such as, heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, SPS, and/or the like, which similarly occupies at least a portion of the inner volume defined by the sample reservoir.
  • a sample reservoir can be any suitable container used to collect a specimen.
  • culture medium can be used to describe a substance configured to react with organisms in a bodily fluid (e.g., microorganisms such as bacteria) and the term “additive” can be used to describe a substance configured to react with portions of the bodily fluid (e.g., constituent cells of blood, serum, synovial fluid, etc.), it should be understood that a sample reservoir can include any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc.
  • the additive could be a culture medium, such as an aerobic culture medium and/or an anaerobic culture medium contained in a culture bottle, an additive and/or any other suitable substance or combination of substances contained in a culture bottle and/or any other suitable reservoir such as those described above. That is to say, the embodiments described herein can be used with any suitable fluid reservoir or the like containing any suitable substance. Furthermore, any of the embodiments and/or methods described herein can be used to transfer a volume of bodily fluid to a reservoir (or the like) that does not contain a culture medium, additive, and/or any other substance prior to receiving a flow of bodily fluid.
  • the embodiments described herein and/or portions thereof can be formed or constructed of one or more biocompatible materials.
  • the biocompatible materials can be selected based on one or more properties of the constituent material such as, for example, stiffness, toughness, durometer, bioreactivity, etc.
  • suitable biocompatible materials include metals, glasses, ceramics, or polymers.
  • suitable metals include pharmaceutical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and/or alloys thereof.
  • a polymer material may be biodegradable or non-biodegradable.
  • suitable biodegradable polymers include polylactides, polyglycolides, polylactide-co-glycolides (PLGA), polyanhydrides, polyorthoesters, polyetheresters, polycaprolactones, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes, and/or blends and copolymers thereof.
  • non-biodegradable polymers include nylons, polyesters, polycarbonates, polyacrylates, polymers of ethylene-vinyl acetates and other acyl substituted cellulose acetates, non-degradable polyurethanes, polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulphonate polyolefins, polyethylene oxide, and/or blends and copolymers thereof.
  • the embodiments described herein and/or portions thereof can include components formed of one or more parts, features, structures, etc.
  • the components can be formed by a singular part having any number of sections, regions, portions, and/or characteristics, or can be formed by multiple parts or features.
  • a structure such as a wall or chamber
  • the structure can be considered as a single structure with multiple portions, or multiple, distinct substructures or the like coupled to form the structure.
  • a monolithically constructed structure can include, for example, a set of substructures.
  • Such a set of substructures may include multiple portions that are either continuous or discontinuous from each other.
  • a set of substructures can also be fabricated from multiple items or components that are produced separately and are later joined together (e.g., via a weld, an adhesive, or any suitable method).
  • FIG. 1 is a schematic illustration of a fluid control device 100 according to an embodiment.
  • the fluid control device 100 (also referred to herein as “control device” or “device”) is configured to withdraw bodily fluid from a patient.
  • a first portion or amount (e.g., an initial amount) of the withdrawn bodily fluid is sequestered from a second portion or amount (e.g., a subsequent amount) of the withdrawn bodily fluid which can be subsequently used for additional testing, discarded, and/or reinfused into the patient.
  • contaminants or the like can be sequestered within the first portion or amount, leaving the second portion or amount substantially free of contaminants.
  • the second portion or amount of bodily fluid can then be used as a biological sample in one or more tests for the purpose of medical diagnosis and/or treatment (e.g., a blood culture test or the like), as described in more detail herein.
  • the first portion or amount of bodily fluid can be discarded as waste or can be used in any suitable test that is less likely to produce false, inaccurate, distorted, inconsistent, and unreliable results as a result of potential contaminants contained therein. In other instances, the first portion or amount of bodily fluid can be infused back into the patient.
  • the control device 100 includes a housing 130 that has and/or forms an inlet 131 , at least one outlet 136 , and a sequestration chamber 134 .
  • the inlet 131 is configured to fluidically couple to a lumen-containing device, which in turn, can place the housing 130 in fluid communication with a bodily fluid source.
  • the housing 130 can be coupled to and/or can include a lumen-containing device that is in fluid communication with the inlet 131 and that is configured to be percutaneously disposed in a patient (e.g., a butterfly needle, intravenous (IV) catheter, peripherally inserted central catheter (PICC), syringe, sterile tubing, intermediary lumen-containing device, and/or bodily-fluid transfer device or the like).
  • a lumen-containing device that is in fluid communication with the inlet 131 and that is configured to be percutaneously disposed in a patient (e.g., a butterfly needle, intravenous (IV) catheter, peripherally inserted central catheter (PICC), syringe, sterile tubing, intermediary lumen-containing device, and/or bodily-fluid transfer device or the like).
  • IV intravenous
  • PICC peripherally inserted central catheter
  • syringe sterile tubing
  • intermediary lumen-containing device e.g., ster
  • the outlet(s) 136 can be placed in fluid communication with a fluid collection device 180 (e.g., a fluid or sample reservoir, syringe, evacuated container, etc.).
  • a fluid collection device 180 e.g., a fluid or sample reservoir, syringe, evacuated container, etc.
  • the control device 100 can be used and/or manipulated to selectively transfer a volume of bodily fluid from a bodily fluid source, through the inlet 131 , the housing 130 , and the outlet(s) 136 to the fluid collection device 180 , as described in further detail herein.
  • the housing 130 defines one or more fluid flow paths 133 between the inlet 131 and the sequestration chamber 134 and/or one or more fluid flow paths 154 between the inlet 131 and the outlet 136 .
  • the housing 130 of the device 100 can be any suitable shape, size, and/or configuration.
  • the housing 130 can have a size that is at least partially based on a volume of bodily fluid at least temporarily stored, for example, in the sequestration chamber 134 .
  • the control device 100 and/or the housing 130 can be configured to transition between operating modes such that bodily fluid flows through at least one of the fluid flow paths 133 and/or 154 .
  • control device 100 and/or the housing 130 can be configured to transition automatically (e.g., based on pressure differential, time, electronically, saturation of a membrane, an absorbent and/or barrier material, etc.) or via intervention (e.g., user intervention, mechanical intervention, or the like).
  • the sequestration chamber 134 is at least temporarily placed in fluid communication with the inlet 131 via the fluid flow path(s) 133 .
  • the sequestration chamber 134 is configured to (1) receive a flow and/or volume of bodily fluid from the inlet 131 and (2) sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid therein.
  • the sequestration chamber 134 can have any suitable arrangement such as, for example, those described herein with respect to specific embodiments. It should be understood, however, that the control device 100 and/or the housing 130 can have a sequestration chamber 134 in any suitable arrangement and is not intended to be limited to those shown and described herein.
  • the sequestration chamber 134 can be at least partially formed by the housing 130 .
  • the sequestration chamber 134 can be a reservoir placed and/or disposed within a portion of the housing 130 .
  • the sequestration chamber 134 can be formed and/or defined by a portion of the fluid flow path 133 .
  • the housing 130 can define one or more lumens and/or can include one or more lumen defining device(s) configured to receive a flow of bodily fluid from the inlet 131 , thereby defining the fluid flow path 133 .
  • at least a portion of the lumen and/or a portion of the lumen defining device(s) can form and/or can define the sequestration chamber 134 .
  • the sequestration chamber 134 can have any suitable volume and/or fluid capacity.
  • the sequestration chamber 134 can have a volume and/or fluid capacity between about 0.25 mL and about 5.0 mL.
  • the sequestration chamber 134 can have a volume measured in terms of an amount of bodily fluid (e.g., the initial or first amount of bodily fluid) configured to be transferred in the sequestration chamber 134 .
  • the sequestration chamber 134 can have a volume sufficient to receive an initial volume of bodily fluid as small as a microliter or less of bodily fluid (e.g., a volume as small as 20 drops of bodily fluid, 10 drops of bodily fluid, 5 drops of bodily fluid, a single drop of bodily fluid, or any suitable volume therebetween).
  • the sequestration chamber 134 can have a volume sufficient to receive an initial volume of bodily fluid up to, for example, about 5.0 mL, 10.0 mL, 15 mL, 20 mL, 30 mL, 40 mL, 50 mL, or more.
  • the sequestration chamber 134 can have a volume that is equal to a fraction of and/or a multiple of at least some of the volumes of one or more lumen(s) placing the sequestration chamber 134 in fluid communication with the bodily fluid source.
  • the sequestration chamber 134 can include any suitable arrangement, configuration, and/or feature, and/or can be formed of one or more materials configured to interact with a portion of the bodily fluid transferred into the sequestration chamber 134 .
  • the housing 130 can include an absorbent and/or hydrophilic material disposed within the sequestration chamber 134 .
  • the absorbent and/or hydrophilic material can absorb, attract, retain, expand, and/or otherwise interact with at least a portion of the bodily fluid, which in turn, can sequester and/or retain at least an initial portion of the bodily fluid within the sequestration chamber 134 , as described in further detail herein.
  • the sequestration chamber 134 can include and/or can be formed of an expandable or collapsible material configured to transition between a first state (e.g., while an initial portion of the bodily fluid is being transferred into the sequestration chamber 134 ) to a second state (e.g., after the initial portion of the bodily fluid is transferred into the sequestration chamber 134 ).
  • a force associated with and/or resulting from such a material expanding or collapsing can be operable to transition the housing 130 and/or the device 100 from a first state, position, configuration, etc. to a second state, position, configuration, etc.
  • the sequestration chamber 134 and/or any other suitable portion of the housing 130 can include one or more chemicals, compounds, and/or the like configured to chemically interact with bodily fluid transferred through a portion of the housing 130 , which can be operable to transition the control device 100 and/or the housing 130 between the first state and the second state (e.g., via a force or any other suitable means).
  • control device 100 and/or the housing 130 can include and/or define a flow controller 120 configured to selectively control a flow of fluids (e.g., gas or liquids) through a portion of the control device 100 .
  • the flow controller 120 can control a flow of bodily fluid through the control device 100 (or housing 130 ) and/or otherwise selectively control a flow of bodily fluid through at least one of the fluid flow paths 133 and/or 154 .
  • the flow controller 120 can be, for example, a valve, a membrane, a diaphragm, a restrictor, a vent, a selectively permeable member (e.g., a fluid impermeable barrier or seal that at least selectively allows the passage of air or gas therethrough), a port, a junction, an actuator, and/or the like, or any suitable combination thereof.
  • the flow controller 120 can be configured to selectively control (at least in part) a flow of fluids into and/or out of the sequestration chamber 134 and/or any other suitable portion of the housing 130 .
  • the flow of fluids can be a liquid such as water, oil, dampening fluid, bodily fluid, and/or any other suitable liquid, and/or can be a gas such as air, oxygen, carbon dioxide, helium, nitrogen, ethylene oxide, and/or any other suitable gas.
  • a wall or structure of the housing 130 can define an opening, aperture, port, orifice, and/or the like that is in fluid communication with the sequestration chamber 134 .
  • the flow controller 120 can be, for example, a semi-permeable member or membrane disposed in or about the opening to selectively allow a flow of air or gas through the opening while limiting or substantially preventing a flow of fluid (e.g., bodily fluid such as blood) through the opening.
  • a semi-permeable member or membrane disposed in or about the opening to selectively allow a flow of air or gas through the opening while limiting or substantially preventing a flow of fluid (e.g., bodily fluid such as blood) through the opening.
  • one or more flow controllers 120 or the like can be configured to facilitate air (or other fluid) displacement through one or more portions of the control device 100 , which in some instances, can result in a pressure differential across one or more portions of the control device 100 or can result in and/or allow for a pressure equalization across one or more portions of the housing 130 .
  • the control device 100 can be configured to selectively transfer a volume of bodily fluid to the sequestration chamber 134 or to the outlet 136 based at least in part on a pressure differential between two or more portions of the control device 100 .
  • the pressure differential can result from fluidically coupling the outlet 136 to the fluid collection device 180 , which can define and/or can be configured to produce a negative pressure (e.g., an evacuated reservoir, a syringe, a pressure charged canister, and/or other source or potential energy to create a vacuum or pressure differential).
  • a negative pressure e.g., an evacuated reservoir, a syringe, a pressure charged canister, and/or other source or potential energy to create a vacuum or pressure differential.
  • the pressure differential can result from a change in volume and/or temperature.
  • the pressure differential can result from at least a portion of the control device 100 , the housing 130 , and/or other portions of the flow path being evacuated and/or charged (e.g., the sequestration chamber 134 and/or any other suitable portion).
  • the pressure differential can be established automatically or via direct or indirect intervention (e.g., by the user).
  • a flow of a fluid (e.g., gas and/or liquid) resulting from a pressure differential can be selectively controlled via one or more flow controllers 120 that can, for example, transition between one or more operating conditions to control the fluid flow.
  • the flow controller 120 can be an actuator or the like configured to transition between one or more operating conditions or states to establish fluid communication between one or more portions of the control device 100 and/or configured to sequester one or more portions of the control device 100 (e.g., the sequestration chamber 134 ).
  • the flow controller 120 can be member or device formed of an absorbent material configured to selectively allow fluid flow therethrough.
  • such an absorbent material can be transitioned from a first state in which the material allows a flow of gas (e.g., air) therethrough but prevents a flow of liquid (e.g., bodily fluid) therethrough, to a second state in which the material substantially prevents a flow of gas and liquid therethrough.
  • the flow controller 120 can include one or more valves, membranes, diaphragms, and/or the like.
  • the flow controller 120 can include any suitable combination of devices, members, and/or features. It should be understood that the flow controllers included in the embodiments described herein are presented by way of example and not limitation. Thus, while specific flow controllers are described herein, it should be understood that fluid flow can be controlled through the control device 100 by any suitable means.
  • the outlet(s) 136 is/are in fluid communication with and/or is/are configured to be placed in fluid communication with the fluid flow paths 133 and/or 154 .
  • the outlet 136 can be any suitable outlet, opening, port, stopcock, lock, seal, coupler, valve (e.g. one-way, check valve, duckbill valve, umbrella valve, and/or the like), etc. and is configured to be fluidically coupled to the fluid collection device 180 (e.g., a fluid reservoir, culture sample bottle, syringe, container, vial, dish, receptacle, pump, adapter, and/or any other suitable collection or transfer device).
  • the outlet 136 can be monolithically formed with the fluid collection device 180 .
  • the outlet 136 can be at least temporarily coupled to the fluid collection device 180 via an adhesive, a resistance fit, a mechanical fastener, a threaded coupling, a piercing or puncturing arrangement, any number of mating recesses, and/or any other suitable coupling or combination thereof.
  • the outlet 136 can be physically (e.g., mechanically) and/or fluidically coupled to the fluid collection device 180 such that an interior volume defined by the fluid collection device 180 is in fluid communication with the outlet 136 .
  • the outlet 136 can be operably coupled to the fluid collection device 180 via an intervening structure (not shown in FIG. 1 ), such as a flexible sterile tubing.
  • the arrangement of the outlet 136 can be such that the outlet 136 is physically and/or fluidically sealed prior to coupling to the fluid collection device 180 .
  • the outlet 136 can be transitioned from a sealed configuration to an unsealed configuration in response to being coupled to the fluid collection device 180 and/or in response to a negative pressure differential between an environment within the outlet 136 and/or housing 130 and an environment within the fluid collection device 180 .
  • the fluid collection device 180 can be any suitable device for at least temporarily containing a bodily fluid, such as, for example, any of those described in detail above.
  • the fluid collection device 180 can be a single-use disposable collection tube(s), a syringe, a vacuum-based collection tube(s), an intermediary bodily-fluid transfer device, and/or the like.
  • the fluid collection device 180 can be substantially similar to or the same as known sample containers such as, for example, a Vacutainer® (manufactured by BD), a BacT/ALERT® SN or BacT/ALERT® FA (manufactured by Biomerieux, Inc.), and/or any suitable reservoir, vial, microvial, microliter vial, nanoliter vial, container, microcontainer, nanocontainer, and/or the like.
  • a Vacutainer® manufactured by BD
  • BacT/ALERT® SN or BacT/ALERT® FA manufactured by Biomerieux, Inc.
  • the fluid collection device 180 can be a sample reservoir that includes a vacuum seal that maintains negative pressure conditions (vacuum conditions) inside the sample reservoir, which in turn, can facilitate withdrawal of bodily fluid from the patient, through the control device 100 , and into the sample reservoir, via a vacuum or suction force, as described in further detail herein.
  • negative pressure conditions vacuum conditions
  • the user can couple the fluid collection device 180 to the outlet 136 to initiate a flow of bodily fluid from the patient such that a first or initial portion of the bodily fluid is transferred into and sequestered by the sequestration chamber 134 and such that any subsequent portion or volume of bodily fluid bypasses and/or is otherwise diverted away from the sequestration chamber 134 and flows into the fluid collection device 180 , as described in further detail herein.
  • control device 100 can be used in conjunction with any suitable bodily fluid collection device and/or system.
  • control device 100 described herein can be used in any suitable fluid transfer device such as those described in U.S. Patent Publication No. 2015/0342510 entitled, “Sterile Bodily-Fluid Collection Device and Methods,” filed Jun. 2, 2015 (referred to herein as the “'510 publication”), the disclosure of which is incorporated herein by reference in its entirety.
  • control device 100 can be used in an “all-in-one” or pre-assembled device (e.g., such as those described in the '510 publication) to receive and sequester an initial volume of bodily fluid such that contaminants in subsequent volumes of bodily fluid are reduced and/or eliminated.
  • an “all-in-one” or pre-assembled device e.g., such as those described in the '510 publication
  • the device 100 can be used to procure a bodily fluid sample having reduced contamination from microbes such as, for example, dermally residing microbes, and/or the like.
  • a user such as a doctor, physician, nurse, phlebotomist, technician, etc. can manipulate the device 100 to establish fluid communication between the inlet 131 and the bodily fluid source (e.g., a vein of a patient, cerebral spinal fluid (CSF) from the spinal cavity, urine collection, and/or the like).
  • the bodily fluid source e.g., a vein of a patient, cerebral spinal fluid (CSF) from the spinal cavity, urine collection, and/or the like.
  • CSF cerebral spinal fluid
  • the inlet 131 can be coupled to and/or can include a needle or the like that can be manipulated to puncture the skin of the patient and to insert at least a portion of the needle in the vein of the patient, thereby placing the inlet 131 in fluid communication with the bodily fluid source (e.g., the vein, an IV catheter, a PICC, etc.).
  • the bodily fluid source e.g., the vein, an IV catheter, a PICC, etc.
  • the outlet 136 can be fluidically coupled to the fluid collection device 180 .
  • the fluid collection device 180 can be any suitable reservoir, container, and/or device configured to receive a volume of bodily fluid.
  • the fluid collection device 180 can be an evacuated reservoir or container that defines a negative pressure and/or can be a syringe that can be manipulated to produce a negative pressure.
  • coupling the outlet 136 to the fluid collection device 180 selectively exposes at least a portion of the fluid flow paths 133 and/or 154 to the negative pressure, thereby resulting in a negative pressure differential operable in drawing bodily fluid from the bodily fluid source (e.g., the patient), through the inlet 131 , and into the housing 130 .
  • the arrangement of the housing 130 is such that when a volume of bodily fluid is transferred to and/or through the inlet 131 , an initial portion of the volume of bodily fluid (also referred to herein as an “initial volume” or a “first volume”) flows from the inlet 131 , through at least a portion of the fluid flow path 133 , and into the sequestration chamber 134 . That is to say, in some embodiments, the control device 100 and/or the housing 130 can be in first or initial state in which the initial portion or volume of bodily fluid can flow in or through at least a portion the fluid flow path 133 and into the sequestration chamber 134 .
  • the initial state of the control device 100 and/or the housing 130 can be one in which one or more flow controllers 120 (e.g., valves, membranes, diaphragms, restrictors, vents, air permeable and fluid impermeable barriers, ports, actuators, and/or the like, or a combination thereof) are in a first state in which the fluid flow path 133 is exposed to the negative pressure differential via the sequestration chamber 134 .
  • one or more flow controllers 120 e.g., valves, membranes, diaphragms, restrictors, vents, air permeable and fluid impermeable barriers, ports, actuators, and/or the like, or a combination thereof
  • the negative pressure within or created by the fluid collection device 180 can result in a negative pressure (or negative pressure differential) within at least a portion of the sequestration chamber 134 that is operable in drawing an initial flow of bodily fluid into the sequestration chamber 134 when one or more flow controllers 120 is/are in a first or initial state.
  • the flow controller 120 can be an actuator or the like that includes a valve (e.g. one-way valve, check valve, duckbill valve, umbrella valve, and/or the like), a selectively permeable member (e.g., a fluid impermeable barrier or seal that allows at least selective passage of gas or air), a selectively permeable membrane, a diaphragm, and/or the like that is at least temporarily fluidically coupled to a flow path between the fluid collection device 180 and the sequestration chamber 134 (e.g., at least a portion of the fluid flow path 154 ).
  • a valve e.g. one-way valve, check valve, duckbill valve, umbrella valve, and/or the like
  • a selectively permeable member e.g., a fluid impermeable barrier or seal that allows at least selective passage of gas or air
  • a selectively permeable membrane e.g., a diaphragm, and/or the like that is at least temporarily fluidically coupled to a
  • the flow controller 120 examples noted above can be, for example, known off-the-shelf components that are used in medical devices to control the flow of fluids and air
  • the flow controller 120 can be a custom, proprietary, and/or specifically tailored component integrated into the device 100 .
  • the flow controller 120 can allow a flow of fluid therethrough in response to the negative pressure of the fluid collection device 180 .
  • the flow controller 120 or a portion or component thereof is configured to allow only a flow of air or gas through the flow controller 120 and is configured to limit and/or substantially prevent a flow of liquid (e.g., bodily fluid) through the flow controller 120 .
  • the fluid collection device 180 can produce a negative pressure differential within the sequestration chamber 134 that is operable to draw an initial portion and/or amount of bodily fluid into the sequestration chamber 134 when the flow controller 120 is in a first or initial state without allowing the initial portion of bodily fluid to flow into the fluid flow path 154 and/or otherwise out of the sequestration chamber 134 .
  • control device 100 and/or the housing 130 can include a member, device, mechanism, feature, etc. configured to modulate a magnitude of the negative pressure to which the sequestration chamber 134 is exposed.
  • a housing can include a valve, a membrane, a porous material, a restrictor, an orifice, and/or any other suitable member, device, and/or feature configured to modulate pressure.
  • modulating and/or controlling a magnitude of the pressure to which the sequestration chamber 134 is exposed can, in turn, modulate a magnitude of pressure exerted on the bodily fluid and/or within a vein of a patient.
  • such pressure modulation can reduce, for example, hemolysis of a blood sample and/or a likelihood of collapsing a vein (e.g., which is particularly important in fragile patients needing microbial and/or other diagnostic testing associated with use of the control device 100 ).
  • the modulation of the negative pressure can, for example, at least partially control a rate at which the control device 100 transitions between a first configuration or state and a second configuration or state.
  • modulating the negative pressure can act like a timer. For example, a time between the introduction of the negative pressure differential and the transitioning of the control device 100 from the first state to the second state can be known, predetermined, calculated, and/or controlled.
  • modulating the negative pressure can at least partially control an amount or volume of bodily fluid transferred into the sequestration chamber 134 (i.e., can control a volume of the initial amount of bodily fluid).
  • the initial portion and/or amount of bodily fluid can be any suitable volume of bodily fluid, as described above.
  • the control device 100 and/or the housing 130 can remain in the first state until a predetermined and/or desired volume (e.g., the initial volume) of bodily fluid is transferred to the sequestration chamber 134 .
  • the initial volume can be associated with and/or at least partially based on a volume of the sequestration chamber 134 .
  • the initial volume can be associated with and/or at least partially based on an amount or volume of bodily fluid that can be absorbed by an absorbent material, an expandable material, a hydrophilic material, a wicking material, and/or other suitable material disposed in the sequestration chamber 134 .
  • the initial volume of bodily fluid can be associated with and/or at least partially based on an amount or volume of bodily fluid that can be transferred into the sequestration chamber 134 in a predetermined time.
  • the initial volume can be associated with and/or at least partially based on an amount or volume of bodily fluid that is sufficient to fully wet or saturate a semi-permeable member or membrane otherwise configured to selectively expose the sequestration chamber 134 to the negative pressure of the fluid collection device 180 (i.e., the flow controller 120 such as an air permeable and liquid impermeable member or membrane).
  • the initial volume of bodily fluid can be a volume sufficient to transition one or more flow controllers 120 to a second state (e.g., a saturated or fully wetted state).
  • control device 100 and/or the housing 130 can be configured to transfer a volume of bodily fluid (e.g., the initial volume) into the sequestration chamber 134 until a pressure differential between the sequestration chamber 134 and the fluid flow path 133 and/or the bodily fluid source is brought into substantial equilibrium and/or is otherwise reduced below a desired threshold.
  • a volume of bodily fluid e.g., the initial volume
  • the initial volume of bodily fluid is transferred and/or diverted into the sequestration chamber 134 , the initial volume is sequestered, segregated, retained, contained, isolated, etc. in the sequestration chamber 134 .
  • the transitioning of the one or more flow controllers 120 from a first state to a second state can be operable to sequester and/or retain the initial portion of the bodily fluid in the sequestration chamber 134 .
  • contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event, other external sources of contamination, colonization of catheters and PICC lines that are used to collect samples, and/or the like can be entrained and/or included in the initial volume of the bodily fluid and thus, are sequestered in the sequestration chamber 134 when the initial volume is sequestered therein.
  • the device 100 can transition to the second state in which a subsequent volume(s) of bodily fluid can flow through at least a portion the fluid flow paths 133 and/or 154 from the inlet 131 to the outlet 136 .
  • the control device 100 and/or the housing 130 can passively and/or automatically transition (e.g., without user intervention) from the first state to the second state once the initial volume of bodily fluid is sequestered in the sequestration chamber 134 .
  • filling the sequestration chamber 134 to capacity and/or fully saturating, wetting, and/or impregnating an absorbent or similar material disposed between the sequestration chamber 134 and the fluid collection device 180 can be such that further transfer of bodily fluid into the sequestration chamber 134 is limited and/or substantially prevented due to a removal or diversion of the negative pressure.
  • the control device 100 and/or the housing 130 can be manually transitioned or transitioned in response to at least an indirect interaction by a user.
  • a user can transition the control device 100 and/or the housing 130 from the first state to the second state by actuating an actuator or the like (e.g., actuating the flow controller 120 or a portion thereof).
  • at least a portion of the initial volume of bodily fluid can transition the control device 100 and/or the housing 130 from the first state to the second state.
  • the control device 100 can include a flow controller 120 that is and/or that includes a bodily fluid activated switch, valve, port, and/or the like.
  • a volume of bodily fluid can move and/or displace one or more flow controller 120 (e.g., actuators or the like) that can, for example, open a port, flow path, and/or outlet.
  • a user can manipulate such a flow controller 120 (e.g., switch, valve, port, actuator, etc.) to transition the control device 100 and/or the housing 130 from the first state to the second state.
  • any subsequent volume(s) of the bodily fluid can flow from the inlet 131 , through at least one of the fluid flow paths 133 and/or 154 , through the outlet 136 , and into the fluid collection device 180 .
  • sequestering the initial volume of bodily fluid in the sequestration chamber 134 prior to collecting or procuring one or more sample volumes of bodily fluid reduces and/or substantially eliminates an amount of contaminants in the one or more sample volumes.
  • the arrangement of the control device 100 and/or the housing 130 can be such that the control device 100 and/or the housing 130 cannot transition to the second state prior to collecting and sequestering the initial volume in the sequestration chamber 134 .
  • FIGS. 2-5 illustrate a fluid control device 200 according to an embodiment.
  • the fluid control device 200 can be similar in at least form and/or function to the fluid control device 100 described above with reference to FIG. 1 . Accordingly, portions of the fluid control device 200 that can be similar to portions of the fluid control device 100 are not described in further detail herein.
  • the fluid control device 200 (also referred to herein as “control device” or “device”) includes a housing 230 having an inlet 231 , an outlet 236 , and an actuator 250 .
  • the inlet 231 is configured to be placed in fluid communication with a bodily fluid source to receive a flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle, IV catheter, PICC line, or the like).
  • the outlet 236 is configured to be fluidically coupled to a fluid collection device such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device or vessel (e.g., a transfer device similar to those described in the '510 publication), and/or the like.
  • a fluid collection device such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device or vessel (e.g., a transfer device similar to those described in the '510 publication), and/or the like.
  • the housing 230 defines one or more fluid flow paths 233 between the inlet 231 and a sequestration chamber 234 and/or one or more fluid flow paths 254 between the inlet 231 and the outlet 236 .
  • the housing 230 of the device 200 can be any suitable shape, size, and/or configuration.
  • the housing 230 can be substantially similar in at least form and/or function to the housing 130 described above with reference to FIG. 1 .
  • the sequestration chamber 234 of the housing 230 is at least temporarily placed in fluid communication with the inlet 231 via the fluid flow path(s) 233 .
  • the sequestration chamber 234 can be selectively placed in fluid communication with the fluid flow path 254 such that at least air or gas can be transferred therebetween, as described in further detail herein.
  • the sequestration chamber 234 is configured to (1) receive a flow and/or volume of bodily fluid from the inlet 231 and (2) sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid therein.
  • the sequestration chamber 234 can have any suitable shape, size, and/or configuration.
  • the sequestration chamber 234 can have any suitable size, volume, and/or fluid capacity such as, for example, those described above with reference to the sequestration chamber 134 .
  • the sequestration chamber 234 can be at least partially formed by the housing 230 that defines a lumen or flow path.
  • At least a portion of the fluid flow path 233 can extend through a portion of the housing 230 to form and/or define at least a portion of the sequestration chamber 234 .
  • the sequestration chamber 234 and/or a portion of the fluid flow path 233 forming the sequestration chamber 234 can have a serpentine configuration or the like.
  • the sequestration chamber 234 can have any suitable arrangement.
  • a housing can include a sequestration chamber that is formed by a flexible tubing or the like that can be arranged in any suitable shape and/or configuration.
  • the housing 230 and/or the sequestration chamber 234 can include, form, and/or define a flow controller 242 .
  • the flow controller 242 can be, for example, a valve, membrane, diaphragm, restrictor, vent, a selectively permeable member (e.g., a fluid impermeable barrier or seal that allows at least selective passage of gas or air such as, for example, a blood barrier and/or the like), port, etc. (collectively referred to herein as a “flow controller”) configured to selectively control (at least in part) a flow of fluids into and/or out of the sequestration chamber 234 and/or any other suitable portion of the housing 230 . More particularly, in the embodiment shown in FIGS.
  • the flow controller 242 is a selectively permeable fluid barrier (e.g., a blood barrier) that includes and/or is formed of a porous material configured to selectively allow a flow of gas therethrough but to prevent a flow of a liquid therethrough.
  • a selectively permeable fluid barrier e.g., a blood barrier
  • the flow controller 242 is positioned within the housing 230 to selectively establish fluid communication between the sequestration chamber 234 and the fluid flow path 254 .
  • the flow controller 242 can be configured to at least temporarily allow a gas or air to transfer between the fluid flow path 254 and the sequestration chamber 234 and can be configured to substantially prevent a flow of liquid between the fluid flow path 254 and the sequestration chamber 234 , as described in further detail herein.
  • the outlet 236 of the housing 230 is in fluid communication with and/or is configured to be placed in fluid communication with the fluid flow paths 233 and/or 254 .
  • the outlet 236 can be any suitable outlet, opening, port, lock, seal, coupler, etc. and is configured to be fluidically coupled to a fluid collection device such as a sample reservoir, a syringe, container, and/or other sample vessel.
  • the outlet 236 can be monolithically formed with the fluid collection device or can be at least temporarily coupled to the fluid collection device, as described above with reference to the outlet 136 of the housing 130 .
  • the fluid collection device can be any suitable reservoir, container, and/or device for containing a bodily fluid, such as, for example, any of those described in detail above with reference to the fluid collection device 180 .
  • the outlet 236 can be configured to couple to an evacuated sample reservoir.
  • the user can couple the sample reservoir to the outlet 236 to initiate a flow of bodily fluid from the patient such that a first or initial portion of the bodily fluid is transferred into and sequestered by the sequestration chamber 234 and such that any subsequent portion or volume of bodily fluid bypasses and/or is otherwise diverted away from the sequestration chamber 234 and flows into the sample reservoir.
  • the housing 230 includes and/or is coupled to the actuator 250 configured to selectively control a flow of bodily fluid through the housing 230 .
  • the actuator 250 is disposed, for example, between a portion of the fluid flow path 233 and a portion of the fluid flow path 254 .
  • the actuator 250 is shown in FIGS. 3-5 as being positioned apart from, away from, and/or downstream of a junction between the fluid flow path 233 and the sequestration chamber 234 , in other embodiments, the actuator 250 can be disposed at any suitable position within the housing 230 .
  • the actuator 250 can be positioned at and/or can form at least a portion of a junction between the fluid flow path 233 , the sequestration chamber 234 , and the fluid flow path 254 .
  • the actuator 250 can be any suitable shape, size, and/or configuration.
  • the actuator 250 can be any suitable member or device configured to transition between a first state and a second state.
  • the actuator 250 is configured to isolate, sequester, separate, and/or otherwise prevent fluid communication between the fluid flow path 233 and the fluid flow path 254 when in the first state and is configured to place the fluid flow path 233 in fluid communication with the fluid flow path 254 when in the second state.
  • the actuator 250 can be a valve, plunger, seal, membrane, flap, plate, and/or the like. As shown, for example, in FIG.
  • the actuator 250 can include one or more seals 265 configured to selectively establish fluid communication between the fluid flow channels 233 and 254 when the actuator 250 is transitioned from a first state to a second state (e.g., pressed, rotated, moved, activated, switched, slid, etc.).
  • a first state e.g., pressed, rotated, moved, activated, switched, slid, etc.
  • the control device 200 can include any suitable actuator or device configured to selectively establish fluid communication between the fluid flow path 233 and 254 .
  • the control device 200 is presented by way of example only and not limitation.
  • the actuator 250 is shown in FIGS. 2-5 as being disposed in a given position, in other embodiments, the actuator 250 can be placed at any suitable position along the housing 230 .
  • the actuator 250 can be disposed at the junction between the fluid flow path 233 , the sequestration chamber 234 , and the inlet 231 .
  • a flow of bodily fluid can flow directly from the inlet 231 and into the sequestration chamber 234 when the actuator 250 is in the first state and can flow directly from the inlet 231 to the fluid flow path 254 when the actuator 250 is in the second state.
  • the actuator 250 can form a portion of the sequestration chamber 234 such that when the actuator 250 is in the first state, bodily fluid flows from the inlet directly into the sequestration chamber 234 .
  • the actuator 250 can, for example, allow bodily fluid to flow directly from the inlet 231 to the fluid flow path 233 .
  • the actuator 250 can prevent the formation of a junction between the inlet 231 , the sequestration chamber 234 , and the fluid flow path 233 . Moreover, when in the second state, the actuator 250 can be operable in at least partially sequestering the sequestration chamber 234 from the inlet 231 and/or the fluid flow path 233 .
  • the actuator 250 can be actuated and/or transitioned in any suitable manner.
  • the actuator 250 can transition between the first and the second state in response to a manual actuation by the user (e.g., exerting a manual force on a button, slider, switch, rotational member, etc.).
  • the actuator 250 can be configured to automatically transition between the first state and the second state in response to a pressure differential (or lack thereof), a change in potential or kinetic energy, a change in composition or configuration (e.g., a portion of the actuator could at least partially dissolve or transform), and/or the like.
  • the actuator 250 can be mechanically and/or electrically actuated or transitioned based on a predetermined time, volumetric flow rate, flow velocity, etc. While examples of actuators and/or ways in which an actuator can transition are provided herein, it should be understood that they have been presented by way of example only and not limitation. Thus, a control device 200 can include any suitable actuator configured to transition in any suitable manner.
  • the device 200 can be used to procure a bodily fluid sample having reduced contamination from microbes such as, for example, dermally residing microbes, and/or the like.
  • a user such as a doctor, physician, nurse, phlebotomist, technician, etc. can manipulate the device 200 to establish fluid communication between the inlet 231 and the bodily fluid source (e.g., a vein of a patient).
  • the bodily fluid source e.g., a vein of a patient.
  • the outlet 236 can be fluidically coupled to the fluid collection device.
  • the fluid collection device can be, for example, an evacuated reservoir or container that defines a negative pressure and/or can be any other suitable negative pressure source.
  • Coupling the outlet 236 to the fluid collection device selectively exposes at least a portion of the fluid flow path 254 to the negative pressure within the fluid collection device.
  • the flow controller 242 is in fluid communication with the fluid flow path 254 and the sequestration chamber 234 .
  • coupling the outlet 236 to the fluid collection device exposes the sequestration chamber to the negative pressure of the fluid collection device, thereby resulting in a negative pressure differential operable in drawing bodily fluid from the bodily fluid source (e.g., the patient), through the inlet 231 , and into the housing 230 .
  • the arrangement of the housing 230 is such that when a volume of bodily fluid is transferred to and/or through the inlet 231 , an initial portion of the volume of bodily fluid (also referred to herein as an “initial volume” or a “first volume”) flows from the inlet 231 , through at least a portion of the fluid flow path 233 , and into the sequestration chamber 234 . That is to say, in some embodiments, the control device 200 and/or the housing 230 can be in first or initial state in which the initial portion or volume of bodily fluid can flow in or through at least a portion the fluid flow path 233 and into the sequestration chamber 234 .
  • the housing 230 and/or the control device 200 can be in the initial state when the flow controller 242 and the actuator 250 are in a first state, position, configuration, etc.
  • the actuator 250 isolates, separates, segregates, sequesters and/or otherwise prevents direct fluid communication between the fluid flow paths 233 and 254 .
  • the inlet 231 is exposed to the negative pressure differential via the sequestration chamber 234 .
  • the negative pressure within the fluid collection device can result in a negative pressure (or negative pressure differential) within at least a portion of the sequestration chamber 234 that is operable in drawing an initial flow of bodily fluid from the inlet 233 into the sequestration chamber 234 when the housing 230 and/or control device 200 is in the first or initial state.
  • the flow controller 242 can allow a flow of fluid (e.g., a gas or air) therethrough in response to the negative pressure of the fluid collection device (e.g., a sample reservoir, a syringe, or other source of potential energy used to create negative pressure), as described above with reference to the housing 130 .
  • a flow of fluid e.g., a gas or air
  • the housing 230 defines a restricted flow path 232 that places the flow controller 242 in fluid communication with the fluid flow path 254 . More specifically, the restricted flow path 232 is a fluid flow path having a smaller diameter than at least the fluid flow path 254 .
  • the restricted flow path 232 can have a diameter of about 0.0005′′, about 0.001′′, about 0.003′′, about 0.005′′, about 0.01′′, about 0.1′′, about 0.5′′ or more. In other embodiments, the restricted flow path 232 can have a diameter less than 0.0005′′ or greater than 0.5′′. In some embodiments, the restricted flow path 232 can have a predetermined and/or desired length of about 0.01′′, about 0.05′′, about 0.1′′, about 0.15′′, about 0.2′′, about 0.5′′, or more. In other embodiments, the restricted flow path 232 can have a predetermined and/or desired length that is less than 0.01′′ or more than about 0.5′′. Moreover, in some embodiments, a restricted flow path 232 can have any suitable combination of diameter and length to allow for and/or to provide a desired flow characteristic through at least a portion of the control device 200 .
  • the restricted flow path 232 having a smaller diameter results in a lower magnitude of negative pressure being applied through the sequestration chamber than a magnitude of negative pressure when the restricted flow path has a larger diameter.
  • modulating a magnitude of negative pressure can control a rate at which bodily fluid is transferred into the sequestration chamber 234 .
  • a fluid collection device and/or other suitable negative pressure source may produce a negative pressure differential having a magnitude (e.g., a negative magnitude) of about 0.5 pounds per square inch (PSI), about 1.0 PSI, about 2.0 PSI, about 3.0 PSI, about 4.0 PSI, about 5.0 PSI, about 10 PSI, about 12.5 PSI, or about 14.7 PSI (e.g., at or substantially at atmospheric pressure at about sea level).
  • a fluid collection device such as an evacuated container or the like can have a predetermined negative pressure of about 12.0 PSI.
  • the amount of negative pressure to which the sequestration chamber 234 is exposed and/or the rate at which the negative pressure is applied can be controlled, reduced, and/or otherwise modulated.
  • the use of the restricted flow path 232 can result in a delay or ramp up of the negative pressure exerted on or in the sequestration chamber.
  • the restricted flow path 232 is, for example, a gas flow path configured to receive a flow of gas or air but not a flow of a liquid (e.g., bodily fluid).
  • the diameter of the restricted flow path 232 can be sufficiently small to limit and/or prevent a flow of a liquid therethrough.
  • the arrangement of the restricted flow path 232 being disposed between the fluid flow path 254 and the flow controller 242 is such that a flow of bodily fluid and/or any other liquid is substantially prevented by the flow controller 242 (e.g., a selectively permeable barrier or seal).
  • a control device can include any suitable number of restricted flow paths, each of which can have substantially the same diameter or can have varied diameters. For example, in some embodiments, a control device can include up to 100 restricted flow paths or more.
  • each of the restricted flow paths can have a diameter of between about 0.0005′′ and about 0.1′′, between about 0.0005′′ and about 0.05′′, or between about 0.0005′′ and about 0.01′′.
  • multiple restricted flow paths can be configured to (1) selectively provide a flow path between the outlet 236 and the sequestration chamber 234 that exposes the sequestration chamber 234 to the negative pressure differential, and (2) act as a flow controller configured to selectively allow the passage of a gas and/or air while substantially preventing the passage of a liquid (e.g., bodily fluid).
  • modulating and/or controlling a magnitude of the pressure to which the sequestration chamber 234 is exposed can, in turn, modulate a magnitude of pressure exerted on the bodily fluid and/or within a vein of a patient.
  • pressure modulation can reduce, for example, hemolysis of a blood sample and/or a likelihood of collapsing a vein.
  • the ability to modulate and/or control an amount or magnitude of negative pressure can allow the control device 200 to be used across a large spectrum of patients that may have physiological challenges whereby negative pressure is often needed to facilitate collection of bodily fluid such as, for example, blood (i.e. pressure differential between atmospheric pressure and a patient's vascular pressure is not sufficient to facilitate consistent and sufficiently forceful flow) but not so much pressure that a rapid force flattens, collapses, caves-in, and/or otherwise inhibits patency and ability to collect blood.
  • the initial portion and/or amount of bodily fluid can be any suitable volume of bodily fluid, as described in detail above with reference to the control device 100 .
  • the initial volume can be associated with and/or at least partially based on an amount or volume of bodily fluid that is sufficient to fully wet or saturate the flow controller 242 .
  • the initial volume of bodily fluid can be a volume sufficient to transition the flow controller 242 to a second state (e.g., a saturated or fully wetted state).
  • the flow controller 242 is placed in a sealed configuration when transitioned to the second state.
  • the flow controller 242 e.g., the semi-permeable material
  • the flow controller 242 places the flow controller 242 in a sealed configuration in which the flow controller 242 substantially prevents a flow of a liquid and a gas therethrough.
  • transitioning the flow controller 242 to the second state sequesters, blocks, isolates, separates, segregates, and/or otherwise prevents flow through the flow controller 242 between the restricted flow path 232 and the sequestration chamber 234 .
  • the control device 200 and/or the housing 230 can be transitioned to its second state or operating mode to sequester, segregate, retain, contain, isolate, etc. the initial volume in the sequestration chamber 234 .
  • the flow controller 242 is placed in the sealed configuration.
  • the actuator 250 can be actuated to transition from its first state to its second state to establish fluid communication between the fluid flow paths 233 and 254 . As such, the negative pressure otherwise exerted on or through the sequestration chamber 234 is now exerted on or through the fluid flow paths 233 and 254 .
  • bodily fluid can flow from the inlet 231 , through the fluid flow paths 233 and 254 , through the outlet 236 , and into the fluid collection device.
  • the transitioning of the flow controller 242 and the actuator 250 from their respective first states to their respective second states is operable to sequester and/or retain the initial portion of the bodily fluid in the sequestration chamber 234 .
  • contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event, can be entrained and/or included in the initial volume of the bodily fluid and thus, are sequestered in the sequestration chamber 234 when the initial volume is sequestered therein.
  • any subsequent volume(s) of the bodily fluid can flow from the inlet 231 , through the fluid flow paths 233 and 254 , through the outlet 236 , and into the fluid collection device.
  • sequestering the initial volume of bodily fluid in the sequestration chamber 234 prior to collecting or procuring one or more sample volumes of bodily fluid reduces and/or substantially eliminates an amount of contaminants in the one or more sample volumes.
  • the arrangement of the control device 200 and/or the housing 230 can be such that the control device 200 and/or the housing 230 cannot transition to the second state prior to collecting and sequestering the initial volume in the sequestration chamber 234 .
  • FIGS. 6-8 illustrate a fluid control device 300 according to an embodiment.
  • the fluid control device 300 can be similar in at least form and/or function to the fluid control device 100 described above with reference to FIG. 1 and/or the fluid control device 200 described above with reference to FIGS. 2-5 . Accordingly, portions of the fluid control device 300 that can be similar to portions of the fluid control devices 100 and/or 200 are not described in further detail herein.
  • the fluid control device 300 (also referred to herein as “control device” or “device”) includes a housing 330 having an inlet 331 and an outlet 336 , and including or being coupled to an actuator 350 .
  • the inlet 331 is configured to be placed in fluid communication with a bodily fluid source to receive a flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle or the like).
  • the outlet 336 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS. 6-8 ).
  • the housing 330 defines one or more fluid flow paths 333 , 354 A, and 354 B configured to selectively place the inlet 331 in fluid communication with the sequestration chamber 334 and/or the outlet 336 .
  • the housing 330 of the device 300 can be any suitable shape, size, and/or configuration.
  • the housing 330 can be substantially similar in at least form and/or function to the housings 130 and/or 230 described above.
  • the housing 330 can have a size that is at least partially based on a volume of bodily fluid at least temporarily stored, for example, in the sequestration chamber 334 .
  • the sequestration chamber 334 of the housing 330 is at least temporarily placed in fluid communication with the inlet 331 via the fluid flow path(s) 333 . Moreover, the sequestration chamber 334 can be selectively placed in fluid communication with the fluid flow path 354 A such that at least air or gas can be transferred therebetween, as described in further detail herein.
  • the sequestration chamber 334 is configured to (1) receive a flow and/or volume of bodily fluid from the inlet 331 and (2) sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid therein.
  • the sequestration chamber 334 can have any suitable shape, size, and/or configuration.
  • the sequestration chamber 334 can be substantially similar to the sequestration chamber 234 described above with reference to FIGS. 2-5 and thus, is not described in further detail herein.
  • the housing 330 and/or the sequestration chamber 334 include, form, and/or define a flow controller 342 that can be substantially similar to the flow controller 242 described above. As such, the flow controller 342 is positioned within the housing 330 to selectively establish fluid communication between the sequestration chamber 334 and the fluid flow path 354 A, as described in further detail herein.
  • the outlet 336 of the housing 330 is in fluid communication with and/or is configured to be placed in fluid communication with the fluid flow paths 333 , 354 A, and/or 354 B.
  • the outlet 336 is configured to be fluidically coupled to a fluid collection device such as, for example, a sample reservoir, container, vial, negative pressure source, syringe, and/or intermediate control and/or transfer device (not shown in FIGS. 6-8 ).
  • the outlet 336 and the fluid collection device can each be substantially similar to the outlet 236 and fluid collection device, respectively, described above with reference to the control device 200 . Thus, the outlet 336 and fluid collection device are not described in further detail herein.
  • the housing 330 includes and/or is coupled to the actuator 350 , which is configured to selectively control a flow of bodily fluid through the housing 330 .
  • the actuator 350 can be substantially similar in at least function to the actuator 250 described above with reference to FIGS. 2-5 .
  • the actuator 350 is arranged as a plunger and includes a set of seals 365 disposed along an outer surface of the plunger.
  • the actuator 350 has a substantially annular shape and is configured to at least temporarily receive and/or otherwise be disposed about a portion of the flow controller 342 , as shown in FIG. 8 .
  • the actuator 350 is configured to isolate, sequester, separate, and/or otherwise prevent fluid communication between the fluid flow path 333 and the fluid flow path 354 B when in the first state and is configured to place the fluid flow path 333 in fluid communication with the fluid flow path 354 B when in the second state.
  • the device 300 can be used to procure a bodily fluid sample having reduced contamination from microbes such as, for example, dermally residing microbes, and/or the like.
  • a user such as a doctor, physician, nurse, phlebotomist, technician, etc. can manipulate the device 300 to establish fluid communication between the inlet 331 and the bodily fluid source (e.g., a vein of a patient).
  • the bodily fluid source e.g., a vein of a patient.
  • the outlet 336 can be fluidically coupled to the fluid collection device.
  • the fluid collection device can be, for example, an evacuated reservoir, a syringe, and/or any container that defines a negative pressure.
  • Coupling the outlet 336 to the fluid collection device selectively exposes at least a portion of the fluid flow paths 354 A and 354 B to the negative pressure within and/or produced by the fluid collection device.
  • the arrangement of the actuator 350 when in its first state, configuration, and/or position is such that the actuator 350 isolates the fluid flow path 354 B from the fluid flow path 333 and as such, the fluid flow path 333 is not exposed to the negative pressure differential produced by the fluid collection device.
  • the flow controller 342 is in fluid communication with the fluid flow path 354 A and the sequestration chamber 334 . More particularly, the annular arrangement of the actuator 350 allows the flow controller 342 to be in fluid communication with the fluid flow path 354 A (see e.g., FIG. 8 ).
  • the outlet 336 exposes the sequestration chamber 334 to the negative pressure of the fluid collection device, thereby resulting in a negative pressure differential operable in drawing bodily fluid from the bodily fluid source (e.g., the patient), through the inlet 331 , and into the housing 330 .
  • the arrangement of the housing 330 is such that when a volume of bodily fluid is transferred to and/or through the inlet 331 , an initial portion of the volume of bodily fluid (also referred to herein as an “initial volume” or a “first volume”) flows from the inlet 331 and into the sequestration chamber 334 . That is to say, in some embodiments, the housing 330 can be in first or initial state in which the initial portion or volume of bodily fluid can flow from the inlet 331 and into the sequestration chamber 334 .
  • the housing 330 and/or the control device 300 can be in the initial state when the flow controller 342 and the actuator 350 are in a first state, position, configuration, etc.
  • the actuator 350 isolates, separates, segregates, sequesters and/or otherwise prevents direct fluid communication between the fluid flow paths 333 and 354 B.
  • the inlet 331 is exposed to the negative pressure differential via the sequestration chamber 334 .
  • the negative pressure within or produced by the fluid collection device can result in a negative pressure (or negative pressure differential) within at least a portion of the sequestration chamber 334 that is operable in drawing an initial flow of bodily fluid from the inlet 331 into the sequestration chamber 334 when the housing 330 and/or control device 300 is in the first or initial state.
  • a negative pressure or negative pressure differential
  • the initial portion and/or amount of bodily fluid can be any suitable volume of bodily fluid, as described in detail above with reference to the control devices 100 and/or 200 .
  • the initial volume can be associated with and/or at least partially based on an amount or volume of bodily fluid that is sufficient to fully wet or saturate the flow controller 342 .
  • the initial volume of bodily fluid can be a volume sufficient to transition the flow controller 342 to a second state (e.g., a saturated or fully wetted state).
  • a second state e.g., a saturated or fully wetted state.
  • the flow controller 342 is placed in a sealed configuration when transitioned to the second state.
  • transitioning the flow controller 342 to the second state sequesters, blocks, isolates, separates, segregates, and/or otherwise prevents flow through the flow controller 342 .
  • the control device 300 and/or the housing 330 can be transitioned to its second state or operating mode to sequester, segregate, retain, contain, isolate, etc. the initial volume in the sequestration chamber 334 .
  • the flow controller 342 is placed in the sealed configuration and thus, substantially prevents a flow of fluid therethrough.
  • the arrangement of the actuator 350 is such that when the flow controller 342 is placed in the sealed configuration, at least a portion of the negative pressure otherwise being exerted through the flow controller 342 is instead exerted on the actuator 350 , which in turn, is sufficient to transition the actuator 350 from its first state to its second state.
  • the negative pressure is operable to move the actuator 350 from a first position (e.g., the first state) to a second position (e.g., the second state), thereby establishing fluid communication between the fluid flow paths 333 and 354 B.
  • moving the actuator 350 to its second position moves and/or transitions the seals 365 relative to the fluid flow paths 333 and 354 B such that fluid communication is established therebetween.
  • the negative pressure otherwise exerted on or through the sequestration chamber 334 is now exerted on or through the fluid flow paths 333 and 354 B.
  • bodily fluid can flow from the inlet 331 , through the fluid flow paths 333 and 354 B, through the outlet 336 , and into the fluid collection device.
  • the transitioning of the flow controller 342 and the actuator 350 from their respective first states to their respective second states is operable to sequester and/or retain the initial portion of the bodily fluid in the sequestration chamber 334 .
  • contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event, can be entrained and/or included in the initial volume of the bodily fluid and thus, are sequestered in the sequestration chamber 334 when the initial volume is sequestered therein.
  • any subsequent volume(s) of the bodily fluid can flow from the inlet 331 , through the fluid flow paths 333 and 354 B, through the outlet 336 , and into the fluid collection device.
  • sequestering the initial volume of bodily fluid in the sequestration chamber 334 prior to collecting or procuring one or more sample volumes of bodily fluid reduces and/or substantially eliminates an amount of contaminants in the one or more sample volumes.
  • the arrangement of the housing 330 can be such that housing 330 cannot transition to the second state prior to collecting and sequestering the initial volume in the sequestration chamber 334 .
  • FIGS. 9 and 10 illustrate a fluid control device 400 according to an embodiment.
  • the fluid control device 400 can be similar in at least form and/or function to the fluid control device 100 described above with reference to FIG. 1 , the fluid control device 200 described above with reference to FIGS. 2-5 , and/or the fluid control device 300 described above with reference to FIGS. 6-8 . Accordingly, portions of the fluid control device 400 that can be similar to portions of the fluid control devices 100 , 200 , and/or 300 are not described in further detail herein.
  • the fluid control device 400 (also referred to herein as “control device” or “device”) includes a housing 430 having an inlet 431 and an outlet 436 , and having and/or being coupled to an actuator 450 .
  • the inlet 431 is configured to be placed in fluid communication with a bodily fluid source to receive a flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle or the like).
  • the outlet 436 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS. 9 and 10 ).
  • the housing 430 of the control device 400 is configured to (1) receive a flow and/or volume of bodily fluid via the inlet 431 and (2) sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid within the sequestration chamber 434 .
  • the housing 430 can be any suitable shape, size, and/or configuration.
  • the housing 430 can have a size that is at least partially based on a volume of bodily fluid at least temporarily stored, for example, in the sequestration chamber 434 .
  • the housing 430 is arranged (at least in part) as a syringe-like device or the like, as described in further detail herein.
  • the housing 430 defines fluid flow paths 433 and 454 that are selectively in fluid communication with the outlet 436 and that selectively receive a flow of fluid therethrough (e.g., a liquid and/or a gas).
  • the outlet 436 of the housing 430 is in fluid communication with and/or is configured to be placed in fluid communication with the fluid flow paths 433 and/or 454 .
  • the outlet 436 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS. 9 and 10 ).
  • the outlet 436 and the fluid collection device can each be substantially similar to the outlet 236 and fluid collection device, respectively, described above with reference to the control device 200 . Thus, the outlet 436 and fluid collection device are not described in further detail herein.
  • the housing 430 includes and/or is coupled to the actuator 450 configured to selectively control a flow of bodily fluid through the housing 430 .
  • the actuator 450 includes a first plunger 460 and a second plunger 461 movably disposed within the housing 430 and configured to at least partially define the sequestration chamber 434 . More specifically, the actuator 450 is configured to move between a first state in which the inlet 431 is placed in fluid communication with the sequestration chamber 434 ( FIG. 9 ) and a second state in which the inlet 431 is placed in fluid communication with the outlet 436 via the fluid flow path 454 ( FIG. 10 ). In this embodiment, when the actuator 450 and/or housing 430 is in the first state, the inlet 431 is in fluid communication with a portion of the housing 430 defined between the first plunger 460 and the second plunger 461 .
  • the first plunger 460 When in the first state, the first plunger 460 is disposed in a position such that a dampening chamber 437 is defined by the housing 430 on a side of the first plunger 460 opposite the sequestration chamber 434 .
  • the dampening chamber 437 is configured to be placed in fluid communication with the fluid flow path 433 via a port 435 .
  • the port 435 can be an opening, a valve, a membrane, a diaphragm, and/or any other suitable flow controller or the like configured to at least selectively establish fluid communication between the fluid flow path 433 and the dampening chamber 437 .
  • the dampening chamber 437 includes and/or contains a dampening fluid 456 such as a gas (compressed or uncompressed) and/or a liquid (e.g., water, oil, dampening fluid, and/or any other suitable liquid).
  • a dampening fluid 456 such as a gas (compressed or uncompressed) and/or a liquid (e.g., water, oil, dampening fluid, and/or any other suitable liquid).
  • the second plunger 461 When the actuator 450 and/or housing 430 are in the first state, the second plunger 461 is disposed in a position within the housing 430 such that one or more seals 465 formed by or coupled to the second plunger 461 fluidically isolate, separate, and/or sequester the inlet 431 from the fluid flow path 454 . In addition, the second plunger 461 and/or the seals 465 formed by or coupled thereto fluidically isolate the fluid flow path 454 from the sequestration chamber 434 . Thus, when the actuator 450 and/or control device 400 are in the first state, the inlet 431 is in fluid communication with the sequestration chamber 434 and is fluidically isolated from the fluid flow paths 433 and 454 as well as the outlet 436 (see FIG. 9 ).
  • the actuator 450 and/or the control device 400 can be configured to transition to the second state in which the sequestration chamber 434 is sequestered within the housing 430 and the inlet 431 is placed in fluid communication with the fluid flow path 454 (see FIG. 10 ).
  • the device 400 can be used to procure a bodily fluid sample having reduced contamination from microbes such as, for example, dermally residing microbes, and/or the like.
  • a user such as a doctor, physician, nurse, phlebotomist, technician, etc. can manipulate the device 400 to establish fluid communication between the inlet 431 and the bodily fluid source (e.g., a vein of a patient).
  • the bodily fluid source e.g., a vein of a patient.
  • the outlet 436 can be fluidically coupled to the fluid collection device.
  • the fluid collection device can be, for example, an evacuated reservoir or container that defines a negative pressure.
  • the actuator 450 and/or the control device 400 can be in a first or initial state prior to coupling the outlet 436 to the fluid collection device.
  • the fluid flow path 433 is in fluid communication with the dampening chamber 437 and the fluid flow path 454 is fluidically isolated from the inlet 431 and the sequestration chamber 434 (e.g., via the second plunger 461 ).
  • coupling the outlet 436 to the fluid collection device exposes at least a portion of the fluid flow paths 433 and 454 to the negative pressure within the fluid collection device.
  • the second plunger 461 isolates the housing 430 and/or the sequestration chamber 434 from the negative pressure exerted via the fluid flow path 454 .
  • the negative pressure exerted through the fluid flow path 433 can be operable in exerting at least a portion of the negative pressure on the dampening chamber 437 (e.g., via the port 435 ).
  • the port 435 can be transitioned from a closed configuration to an open configuration in response to the negative pressure.
  • the negative pressure exerted through the fluid flow path 433 is operable in transitioning the actuator 450 from a first state to a second state.
  • the negative pressure differential draws the dampening fluid 456 from the dampening chamber 437 and into the fluid flow path 433 or a secondary chamber or the like.
  • the negative pressure urges the first plunger 460 to transition and/or move relative to the housing 430 from a first configuration or position to a second configuration or position.
  • the transitioning and/or moving of the first plunger 460 can be such that a volume of the housing 430 defined between the first plunger 460 and the second plunger 461 is increased (i.e., a volume of the sequestration chamber 434 is increased).
  • the increase in the volume of the sequestration chamber 434 results in a negative pressure therein, which in turn, can be operable in drawing an initial volume of bodily fluid through the inlet 431 and into the sequestration chamber 434 .
  • the negative pressure of the fluid collection device indirectly results in a negative pressure differential between the inlet 431 and the sequestration chamber 434 that is operable in drawing the initial volume of bodily fluid into the sequestration chamber 434 .
  • the arrangement of the actuator 450 is such that after the first plunger 460 has moved a predetermined amount (and/or after the volume of the sequestration chamber 434 has been increased a predetermined amount) and an initial volume of bodily fluid has been drawn into the sequestration chamber 434 , the second plunger 461 is moved or transitioned from a first position and/or configuration to a second position and/or configuration. As such, the actuator 450 is placed in its second state in which the sequestration chamber 434 is sequestered from the inlet 431 .
  • the second plunger 461 and/or the seals 465 coupled thereto place the inlet 431 in fluid communication with the fluid flow path 454 .
  • the negative pressure otherwise exerted on or through the fluid flow path 433 is now exerted on or through the fluid flow path 454 .
  • bodily fluid can flow from the inlet 431 , through the fluid flow path 454 , through the outlet 436 , and into the fluid collection device.
  • the transitioning of the actuator 450 from the first state to the second state is operable to sequester and/or retain the initial portion of the bodily fluid in the sequestration chamber 434 .
  • contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event, can be entrained and/or included in the initial volume of the bodily fluid and thus, are sequestered in the sequestration chamber 434 when the initial volume is sequestered therein.
  • the arrangement of the housing 430 can be such that housing 430 cannot transition to the second state prior to collecting and sequestering the initial volume in the sequestration chamber 434 .
  • the control device 400 is configured to modulate an amount of negative pressure exerted on the first plunger 460 when the actuator 450 is in the first state.
  • the dampening fluid 456 disposed in the dampening chamber 437 reduces a magnitude of the negative pressure exerted on the first plunger 460 .
  • the rate at which the actuator 450 and/or control device 400 is transitioned from the first state to the second state can be controlled.
  • exposing the housing 430 to the full magnitude of the negative pressure may result transitioning the actuator 450 and/or the control device 400 from the first state to the second state prior to receiving the initial volume of bodily fluid in the sequestration chamber 434 .
  • modulating the magnitude of the pressure can ensure a desired volume of bodily fluid is transferred into the sequestration chamber 434 .
  • FIGS. 9 and 10 show that this is presented by way of example only and not limitation. Any other suitable means of dampening and/or modulating a magnitude of the negative pressure can be used to control the transitioning of the actuator 450 and/or housing 430 .
  • FIGS. 11 and 12 illustrate a fluid control device 500 according to an embodiment.
  • the fluid control device 500 can be similar in at least form and/or function to any of the fluid control devices 100 , 200 , 300 , and/or 400 . Accordingly, portions of the fluid control device 500 that can be similar to portions of the fluid control devices 100 , 200 , 300 , and/or 400 are not described in further detail herein. As shown in FIGS.
  • the fluid control device 500 (also referred to herein as “control device” or “device”) includes a housing 530 having an inlet 531 and an outlet 536 , and having and/or being coupled to an actuator 550 .
  • the inlet 531 is configured to be placed in fluid communication with a bodily fluid source to receive a fluid of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle or the like).
  • the outlet 536 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS. 11 and 12 ).
  • the inlet 531 , the outlet 536 , and the fluid collection device can be substantially similar to those described above and thus, are not described in further detail herein.
  • the housing 530 of the control device 500 is configured to (1) receive a flow and/or volume of bodily fluid via the inlet 531 and (2) sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid within the sequestration chamber 534 .
  • the housing 530 can be any suitable shape, size, and/or configuration.
  • the housing 530 can have a size that is at least partially based on a volume of bodily fluid at least temporarily stored, for example, in the sequestration chamber 534 .
  • the housing 530 can be arranged in a substantially similar manner as the housing 430 described above with reference to FIGS. 9 and 10 .
  • the housing 530 can differ from the housing 430 , by arranging the actuator 550 as, for example, a diaphragm rather than one or more plungers.
  • the housing 530 defines a set of fluid flow paths 533 and 554 in fluid communication with the outlet 536 and configured to selectively receive a flow of fluid therethrough (e.g., a liquid and/or a gas).
  • the housing 530 includes and/or is coupled to the actuator 550 configured to selectively control a flow of bodily fluid through the housing 530 .
  • the actuator 550 includes a diaphragm 576 movably disposed within the housing 530 and configured to at least partially define the sequestration chamber 534 . More specifically, the actuator 550 is configured to move between a first state in which the inlet 531 is placed in fluid communication with the sequestration chamber 534 ( FIG. 11 ) and a second state in which the inlet 531 is placed in fluid communication with the outlet 536 via the fluid flow path 554 ( FIG. 12 ).
  • the inlet 531 is in fluid communication with a portion of the housing 530 defined between the diaphragm 576 and one or more seals 565 .
  • the diaphragm 576 is disposed in a first state such that a dampening chamber 537 is defined by the housing 530 on a side of the diaphragm 576 opposite the sequestration chamber 534 , as described above with reference to the housing 430 .
  • the dampening chamber 537 is configured to be placed in fluid communication with the fluid flow path 533 via a port 535 .
  • the port 535 can be an opening, a valve, a membrane, a diaphragm, and/or any other suitable flow controller or the like configured to at least selectively establish fluid communication between the fluid flow path 533 and the dampening chamber 537 .
  • the dampening chamber 537 includes and/or contains a dampening fluid such as a gas (compressed or uncompressed) and/or a liquid (e.g., water, oil, dampening fluid, and/or any other suitable liquid).
  • the arrangement of the dampening chamber 537 , the dampening fluid, and the port 535 can be configured to modulate an amount of negative pressure exerted on the diaphragm 576 when the actuator 550 is in the first state.
  • modulating the negative pressure via the dampening fluid it should be understood that this is presented by way of example only and not limitation. Any other suitable means of dampening and/or modulating a magnitude of the negative pressure can be used to control the transitioning of the actuator 550 and/or the control device 500 .
  • the one or more seals 565 are disposed in a position within the housing 530 such that the one or more seals 565 fluidically isolate, separate, and/or sequester the inlet 531 from the fluid flow path 554 .
  • the one or more seals 565 fluidically isolate the fluid flow path 554 from the sequestration chamber 534 .
  • the inlet 531 is in fluid communication with the sequestration chamber 534 and fluidically isolated from the fluid flow paths 533 and 554 as well as the outlet 536 (see FIG. 11 ).
  • the actuator 550 and/or the control device 500 housing 530 can be configured to transition to the second state in which the sequestration chamber 534 is sequestered within the housing 530 and the inlet 531 is placed in fluid communication with the fluid flow path 554 (see FIG. 12 ).
  • the device 500 can be used to procure a bodily fluid sample having reduced contamination from microbes such as, for example, dermally residing microbes, and/or the like.
  • a user can place the inlet 531 in fluid communication with the bodily fluid source (e.g., the portion of the patient) and can fluidically couple the outlet 536 to the fluid collection device.
  • the actuator 550 and/or the device 500 can be in a first or initial state prior to coupling the outlet 536 to the fluid collection device.
  • the fluid flow path 533 is in fluid communication with the dampening chamber 537 and the fluid flow path 554 is fluidically isolated from the inlet 531 and the sequestration chamber 534 (e.g., via the one or more seals 565 ), as described in detail above with reference to the control device 400 of FIGS. 9 and 10 .
  • Coupling the outlet 536 to the fluid collection device selectively exposes at least a portion of the fluid flow paths 533 and 554 to the negative pressure within and/or produced by the fluid collection device.
  • the one or more seals 565 isolate the housing 530 and/or the sequestration chamber 534 from the negative pressure exerted via the fluid flow path 554 .
  • the negative pressure exerted through the fluid flow path 533 can be operable in exerting at least a portion of the negative pressure on the dampening chamber 537 (e.g., via the port 535 ).
  • the port 535 can be transitioned from a closed configuration to an open configuration in response to the negative pressure.
  • the negative pressure exerted through the fluid flow path 533 is operable in transitioning the actuator 550 from a first state to a second state.
  • the negative pressure differential draws the dampening fluid from the dampening chamber 537 and into the fluid flow path 533 .
  • the negative pressure urges the diaphragm 576 to transition, flip, move, switch, deform, etc., from a first configuration or state ( FIG. 11 ) to a second configuration or state ( FIG. 12 ).
  • the transitioning of the diaphragm 576 from the first state to the second state can be such that a volume of the housing 530 defined between the diaphragm 576 and the one or more seals 565 is increased (i.e., a volume of the sequestration chamber 534 is increased), which in turn, results in a negative pressure therein that can be operable in drawing an initial volume of bodily fluid through the inlet 531 and into the sequestration chamber 534 .
  • movement of the diaphragm 576 results in a similar movement of the one or more seals 565 such that the one or more seals 565 are disposed on the same side of the inlet 531 as the diaphragm 576 .
  • the sequestration chamber 534 is sequestered within the housing 530 .
  • moving the one or more seals 565 is such that fluid communication is established between the inlet 531 and the fluid flow path 554 .
  • the negative pressure otherwise exerted on or through the fluid flow path 533 is now exerted on or through the fluid flow path 554 .
  • bodily fluid can flow from the inlet 531 , through the fluid flow path 554 , through the outlet 536 , and into the fluid collection device, as described in detail above.
  • the transitioning of the actuator 550 from the first state to the second state is operable to sequester and/or retain the initial portion of the bodily fluid in the sequestration chamber 534 , which can include contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event.
  • sequestering the initial volume of bodily fluid in the sequestration chamber 534 prior to collecting or procuring one or more sample volumes of bodily fluid reduces and/or substantially eliminates an amount of contaminants in the one or more sample volumes.
  • the arrangement of the control device 500 and/or the housing 530 can be such that the control device 500 and/or the housing 530 cannot transition to the second state prior to collecting and sequestering the initial volume in the sequestration chamber 534 .
  • FIGS. 13-15 illustrate a fluid control device 600 according to an embodiment.
  • the fluid control device 600 can be similar in at least form and/or function to any of the fluid control devices 100 , 200 , 300 , 400 , and/or 500 . Accordingly, portions of the fluid control device 600 that can be similar to portions of the fluid control devices 100 , 200 , 300 , 400 , and/or 500 are not described in further detail herein.
  • the fluid control device 600 (also referred to herein as “control device” or “device”) includes a housing 630 having an inlet 631 and an outlet 636 , and having and/or being coupled to an actuator 650 .
  • the inlet 631 is configured to be placed in fluid communication with a bodily fluid source to receive a fluid of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle or the like).
  • the outlet 636 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS. 13-15 ).
  • the inlet 631 , the outlet 636 , and the fluid collection device can be substantially similar to those described above and thus, are not described in further detail herein.
  • the housing 630 of the control device 600 is configured to (1) receive a flow and/or volume of bodily fluid via the inlet 631 and (2) sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid within a sequestration chamber 634 included in and/or at least partially formed by the housing 630 .
  • the housing 630 can be any suitable shape, size, and/or configuration.
  • the housing 630 can have a size that is at least partially based on a volume of bodily fluid at least temporarily stored, for example, in the sequestration chamber 634 .
  • the housing 630 can be arranged in a substantially similar manner as the housing 530 described above with reference to FIGS. 11 and 12 . That is to say, the housing 630 includes an actuator 650 that is arranged as a diaphragm.
  • the housing 630 defines a set of fluid flow paths 633 and 654 in fluid communication with the outlet 636 and configured to selectively receive a flow of fluid therethrough (e.g., a liquid and/or a gas).
  • the housing 630 includes and/or is coupled to the actuator 650 configured to selectively control a flow of bodily fluid through the housing 630 .
  • the actuator 650 includes a diaphragm 676 movably disposed within the housing 630 and configured to at least partially define the sequestration chamber 634 .
  • the actuator 650 is configured to move between a first state in which the inlet 631 is placed in fluid communication with the sequestration chamber 634 and a second state in which the inlet 631 is placed in fluid communication with the outlet 636 via the fluid flow path 654 , as described in detail above with reference to the control device 500 .
  • the inlet 631 is in fluid communication with a portion of the housing 630 defined between the diaphragm 676 and one or more seals 665 .
  • the diaphragm 676 is disposed in a first state such that a dampening chamber 637 is defined by the housing 630 on a side of the diaphragm 676 opposite the sequestration chamber 634 , as described above with reference to the housing 530 .
  • the dampening chamber 637 is configured to be placed in fluid communication with the fluid flow path 654 via a port 635 (such as those described above).
  • the dampening chamber 637 includes and/or contains a dampening fluid such as a gas (compressed or uncompressed) and/or a liquid (e.g., water, oil, dampening fluid, and/or any other suitable liquid), that can be configured to modulate an amount of negative pressure exerted on the diaphragm, as described in detail above with reference to the control device 500 .
  • a dampening fluid such as a gas (compressed or uncompressed) and/or a liquid (e.g., water, oil, dampening fluid, and/or any other suitable liquid)
  • a dampening fluid such as a gas (compressed or uncompressed) and/or a liquid (e.g., water, oil, dampening fluid, and/or any other suitable liquid)
  • the seal 665 when the actuator 650 and/or the device 600 are in the first state, the seal 665 is disposed in a position within the housing 630 such that the seal 665 fluidically isolates, separates, and/or sequesters the inlet 631 from the fluid flow path 654 . In addition, the seal 665 fluidically isolates the fluid flow path 654 from the sequestration chamber 634 . Thus, when the actuator 650 and/or the device 600 are in the first state, the inlet 631 is in fluid communication with the sequestration chamber 634 and fluidically isolated from the fluid flow path 654 as well as the outlet 636 .
  • the actuator 650 and/or the device 600 can be configured to transition to the second state in which the sequestration chamber 634 is sequestered within the housing 630 and the inlet 631 is placed in fluid communication with the fluid flow path 654 . Accordingly, the device 600 can be used to procure a bodily fluid sample having reduced contamination from microbes (e.g., dermally residing microbes and/or the like), in a substantially similar manner as the device 500 described above with reference to FIGS. 11 and 12 . Thus, the functioning of the device 600 is not described in further detail herein.
  • microbes e.g., dermally residing microbes and/or the like
  • FIGS. 16-18 illustrate a fluid control device 700 according to an embodiment.
  • the fluid control device 700 can be similar in at least form and/or function to any of the fluid control devices 100 , 200 , 300 , 400 , 500 , and/or 600 . Accordingly, portions of the fluid control device 700 that can be similar to portions of the fluid control devices 100 , 200 , 300 , 400 , 500 , and/or 600 are not described in further detail herein.
  • the fluid control device 700 (also referred to herein as “control device” or “device”) includes a housing 730 having an inlet 731 and an outlet 736 , and having or being coupled to an actuator 750 .
  • the inlet 731 is configured to be placed in fluid communication with a bodily fluid source to receive a fluid of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle or the like).
  • the outlet 736 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS. 16-18 ).
  • the inlet 731 , the outlet 736 , and the fluid collection device can be substantially similar to those described above and thus, are not described in further detail herein.
  • the housing 730 of the control device 700 is configured to (1) receive a flow and/or volume of bodily fluid via the inlet 731 and (2) sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid within the sequestration chamber 734 .
  • the housing 730 can be any suitable shape, size, and/or configuration.
  • the housing 730 can have a size that is at least partially based on a volume of bodily fluid at least temporarily stored, for example, in the sequestration chamber 734 .
  • the housing 730 can be arranged in a substantially similar manner as the housings 530 and/or 630 . That is to say, the housing 530 includes and/or is coupled to the actuator 750 that is arranged as a diaphragm.
  • the housing 730 defines a set of fluid flow paths 733 and 754 in fluid communication with the outlet 736 (see e.g., FIGS. 17A and 17B ) and configured to selectively receive a flow of fluid therethrough (e.g., a liquid and/or a gas).
  • the housing 730 includes and/or is coupled to the actuator 750 configured to selectively control a flow of bodily fluid through the housing 730 .
  • the actuator 750 includes a diaphragm 776 movably disposed within the housing 730 and configured to at least partially define the sequestration chamber 734 .
  • the actuator 750 is configured to move between a first state in which the inlet 731 is placed in fluid communication with the sequestration chamber 734 and a second state in which the inlet 731 is placed in fluid communication with the outlet 736 via the fluid flow path 754 , as described in detail above with reference to the control device 500 .
  • the inlet 731 is in fluid communication with the sequestration chamber 734 formed by a portion of the housing 730 defined between the diaphragm 776 and a flow controller 742 (e.g., a selectively permeable fluid barrier or seal, and/or any other flow controller such as any of those described above).
  • a flow controller 742 e.g., a selectively permeable fluid barrier or seal, and/or any other flow controller such as any of those described above.
  • the diaphragm 776 is disposed in a first state such that the fluid flow path 733 is in fluid communication with the sequestration chamber 734 .
  • the diaphragm 776 and/or the seal 765 are disposed in a position within the housing 730 such that the diaphragm 776 and/or the seal 765 fluidically isolate, separate, and/or sequester the inlet 731 from the fluid flow path 754 .
  • the diaphragm 776 and/or the seal 765 fluidically isolate the fluid flow path 754 from the sequestration chamber 734 .
  • the inlet 731 is in fluid communication with the sequestration chamber 734 and fluidically isolated from the fluid flow path 754 .
  • a negative pressure differential within the sequestration chamber 734 can result from the coupling of the fluid collection device to the outlet 736 .
  • the fluid flow path 733 can be in fluid communication with the outlet 736 and the flow controller 742 .
  • the flow controller 742 can allow a gas or air to pass therethrough.
  • the negative pressure differential within the sequestration chamber 734 can result from the coupling of the fluid collection device to the outlet 736 .
  • the actuator 750 and/or the device 700 can be configured to transition to the second state in which the sequestration chamber 734 is sequestered within the housing 730 and the inlet 731 is placed in fluid communication with the fluid flow path 754 , as described in detail above with reference to the control device 600 . More particularly, an initial volume of bodily fluid can be transferred into the sequestration chamber 734 , which in turn, can saturate, can wet, and/or otherwise can transition the flow controller 742 from the first or open state to a second or closed state. In some embodiments, the transitioning of the flow controller 742 from the first state to the second state is operable in isolating the fluid flow path 733 from the outlet 736 .
  • a negative pressure exerted through the fluid flow path 754 can be operable in transitioning, switching, flipping, moving, deforming, and/or otherwise reconfiguring the diaphragm 776 such that the actuator 750 is placed in its second state.
  • the negative pressure of the fluid collection device can draw bodily fluid from the inlet 731 , through the housing 730 (bypassing the sequestration chamber 734 ), through the fluid flow path 754 and the outlet 736 , and into the fluid collection device, as described in detail above.
  • the device 700 can be used to procure a bodily fluid sample having reduced contamination from microbes (e.g., dermally residing microbes and/or the like), in a manner substantially similar to one or more of the control devices 100 , 200 , 300 , 400 , 500 , and/or 600 described in detail above.
  • microbes e.g., dermally residing microbes and/or the like
  • the functioning of the device 700 is not described in further detail herein.
  • any of the control devices 100 , 200 , 300 , 400 , 500 , 600 , and/or 700 can be formed from any suitable components that can be manufactured, assembled, sterilized, and packaged as an assembly or integrated device.
  • a user can, for example, open a packaging containing such an assembly or integrated device and can use the device as described above with reference to the control devices 100 , 200 , 300 , 400 , 500 , 600 , and/or 700 .
  • any of the control devices can be monolithically formed in whole or at least in part.
  • any of the control devices can be physically coupled, attached, formed, and/or otherwise mated to a fluid collection device (e.g., a sample reservoir, a syringe, a blood culture bottle, a collection vial, a fluid transfer container, and/or any other suitable reservoir, collection device, and/or transfer device) during a manufacturing process.
  • a fluid collection device e.g., a sample reservoir, a syringe, a blood culture bottle, a collection vial, a fluid transfer container, and/or any other suitable reservoir, collection device, and/or transfer device
  • This can be done prior to sterilization so the collection pathway(s) and connection interface(s) (e.g., where the control device couples to the fluid collection device) maintain a closed-system, mechanical diversion device within a sterile environment that is not subject to touch-point contamination from external sources.
  • the coupling, mating, and/or attachment of the fluid control device to the fluid collection device can be executed such that the control device can be removed (physically decoupled, removed with a specific “key,” and/or any other approach used to separate the control device from the fluid collection device) after use to allow access to the fluid collection device, which can then be placed in an incubator and/or any other type of analytical machine, and accessed for analysis and/or otherwise further processed.
  • such decoupling may be blocked, limited, and/or substantially prevented prior to use and unblocked or allowed after use.
  • the fluid control device and the fluid collection device can be permanently coupled and/or monolithically formed (at least in part) to prevent such decoupling.
  • a control device can include one or more modular components that can be selected by a user based on a desired use, preference, patient, etc.
  • the user can couple one or more modular components (packaged together or packaged separately) to form the desired fluid control device.
  • FIGS. 19-25 illustrate a modular fluid control device 800 according to an embodiment.
  • the fluid control device 800 can be similar in at least form and/or function to the fluid control devices described herein. More specifically, portions of the fluid control device 800 can be similar to and/or substantially the same as corresponding portions of the fluid control device 200 described above with reference to FIGS. 2-5 . Accordingly, such portions of the fluid control device 800 are not described in further detail herein.
  • the fluid control device 800 (also referred to herein as “control device” or “device”) includes a housing 830 and an actuator 850 .
  • the control device 800 can be at least partially monolithically formed or can be otherwise preassembled during manufacturing.
  • the control device 800 can be at least partially modular such that a user can physically and fluidically couple the housing 830 and the actuator 850 to form the control device 800 .
  • the housing 830 of the device 800 can be any suitable shape, size, and/or configuration.
  • the housing 830 can be, for example, relatively thin and substantially rectangular.
  • portions of the housing 830 can be substantially similar in at least form and/or function to the housing 230 described above with reference to FIGS. 2-5 . Thus, while such portions are identified, similar components, features, and/or functions are not described in further detail herein.
  • the housing 830 forms and/or defines a sequestration chamber 834 that is in selective fluid communication with a first port 845 and a second port 846 .
  • the first port 845 and the second port 846 are configured to be at least fluidically coupled to a portion of the actuator 850 to allow for selective fluid flow between the housing 830 and the actuator 850 .
  • the sequestration chamber 834 is configured (1) to receive a selective flow and/or volume of bodily fluid from a portion of the actuator 850 via the first port 845 , and (2) to sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid (e.g., an initial or first flow and/or volume of bodily fluid or any portion thereof) within the sequestration chamber 834 .
  • the sequestration chamber 834 can have any suitable shape, size, and/or configuration.
  • the sequestration chamber 834 can have any suitable size, volume, and/or fluid capacity such as, for example, those described above with reference to the sequestration chamber 134 .
  • the sequestration chamber 834 can be, for example, a fluid flow path that extends through and/or that is defined by at least a portion of the housing 830 .
  • the sequestration chamber 834 can be substantially similar in at least form and/or function to the sequestration chamber 234 described above with reference to FIGS. 2-5 and thus, is not described in further detail herein.
  • the housing 830 includes and/or defines a flow controller 842 and a restricted flow path 832 .
  • the flow controller 842 can be, for example, a valve, membrane, diaphragm, restrictor, vent, a selectively permeable member, port, etc. configured to selectively control (at least in part) a flow of fluids into and/or out of the sequestration chamber 834 and/or any other suitable portion of the housing 830 .
  • the flow controller 842 can be a selectively permeable fluid barrier (e.g., a blood barrier) that includes and/or is formed of a porous material configured to selectively allow a flow of gas therethrough but to prevent a flow of a liquid therethrough.
  • the flow controller 842 can be substantially similar to the flow controller 242 described in detail above with reference to FIGS. 2-5 and thus, is not described in further detail herein.
  • the restricted flow path 832 defined by the housing 830 is in fluid communication with the second port 846 and is positioned between the second port 846 and the flow controller 842 (or a portion of the housing 830 receiving or housing the flow controller 842 ).
  • the restricted flow path 832 is a fluid flow path having a smaller diameter than, for example, one or more other flow paths defined by the housing 830 and/or actuator 850 .
  • the restricted flow path 832 can have a diameter between about 0.0005′′ to about 0.5′′ and can have a length between about 0.01′′ and about 0.5′′, as described above with reference to the restricted flow path 232 .
  • the smaller diameter of the restricted flow path 832 results in a lower magnitude of negative pressure being applied through the sequestration chamber 834 than a magnitude of negative pressure when the restricted flow path 832 has a larger diameter.
  • the restricted flow path 832 can be configured to modulate an amount of negative pressure to which the sequestration chamber 834 is exposed. In some instances, modulating the amount of negative pressure can control a rate at which bodily fluid is transferred into the sequestration chamber 834 .
  • the restricted flow path 832 is, for example, a gas flow path configured to receive a flow of gas or air but not a flow of a liquid (e.g., bodily fluid), which can allow for a negative pressure differential sufficient to successfully collect the initial volume of bodily fluid and/or sufficient to transition at least a portion of the control device 800 to a second state, while limiting and/or substantially preventing a portion of the initial or first volume of bodily fluid from being drawn through the sequestration chamber 834 and the second port 846 .
  • a liquid e.g., bodily fluid
  • the actuator 850 includes a body 851 and an actuator rod 862 .
  • the body 851 of the actuator 850 includes an inlet 852 and an outlet 853 .
  • the inlet 852 and the outlet 853 can be substantially similar in at least form and/or function to the inlet 231 and the outlet 236 , respectively, described above with reference to FIGS. 2-5 .
  • the inlet 852 is configured to be placed in fluid communication with a bodily fluid source to receive a flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle, IV catheter, PICC line, or the like).
  • the outlet 853 is configured to be fluidically coupled to a fluid collection device 880 such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device, adapter, or vessel (see e.g., FIG. 25 ) such as, for example, a transfer device similar to those described in the '510 publication.
  • a fluid collection device 880 such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device, adapter, or vessel (see e.g., FIG. 25 ) such as, for example, a transfer device similar to those described in the '510 publication.
  • the body 851 of the actuator 850 includes and/or defines a first port 858 and a second port 859 .
  • the first port 858 is in fluid communication with the inlet 852 and the second port 859 is in fluid communication with the outlet 853 .
  • the first port 858 and the second port 859 are configured to be at least fluidically coupled to the first port 845 and the second port 846 , respectively, of the housing 830 .
  • the actuator 850 can be transitioned between a first operating mode or state and a second operating mode or state to selectively control fluid flow through the ports 858 and 859 of the actuator 850 and the ports 845 and 846 of the housing 830 , which in turn, can selectively control a flow of bodily fluid into and/or out of the sequestration chamber 834 of the housing 830 .
  • the arrangement of the ports 858 and 859 of the actuator 850 and the ports 845 and 846 of the housing 830 can allow for and/or otherwise can provide a means of physically coupling the housing 830 to the actuator 850 as well as fluidically coupling the housing 830 to the actuator 850 .
  • the ports 858 and 859 of the actuator 850 and the ports 845 and 846 of the housing 830 can form a friction fit, a press fit, an interference fit, and/or the like.
  • the ports 858 and 859 of the actuator 850 can be coupled to the ports 845 and 846 , respectively, of the housing 830 via an adhesive, a mechanical fastener, an elastomeric coupling, a gasket, an o-ring(s), and/or any other suitable coupling means.
  • the ports 858 and 859 of the actuator 850 can be physically and fluidically coupled to the ports 845 and 846 , respectively, of the housing 830 via an intervening structure such as, for example, one or more sterile, flexible tubing(s).
  • the device 800 can be and/or can have, for example, a modular configuration in which the housing 830 can be at least fluidically coupled to the actuator 850 .
  • such a modular arrangement can allow a user to select a housing (or actuator) with one or more desired characteristics based on, for example, the intended purpose and/or use of the assembled device.
  • the modular arrangement can allow and/or facilitate one or more components with desired characteristics to be coupled and/or assembled during manufacturing. For example, in some instances, it may be desirable to select a housing that includes and/or defines a sequestration chamber having a particular or desired volume.
  • a housing that defines and/or includes a sequestration chamber with a smaller volume than may otherwise be selected when the device is being used to procure bodily fluid from a seemingly healthy adult patient.
  • a modular arrangement can allow a user (e.g., a doctor, physician, nurse, technician, phlebotomist, etc.) to select a housing or an actuator having one or more desired characteristics based on, for example, the intended use of the device.
  • the modular arrangement can allow or facilitate assembly of a housing or an actuator having one or more desired characteristics during manufacturing without making significant changes to one or more manufacturing processes.
  • the actuator rod 862 of the actuator 850 is movably disposed within a portion of the body 851 .
  • the actuator rod 862 includes a first end portion 863 and a second end portion 864 , at least one of which extends beyond the body 851 of the actuator 850 with the actuator rod 862 is disposed within the body 851 (see e.g., FIGS. 23 and 24 ).
  • a portion of the actuator rod 862 includes and/or is coupled to a set of seals 865 .
  • the seals 865 can be, for example, o-rings, elastomeric over-molds, proud or raised dimensions or fittings, and/or the like.
  • the arrangement of the actuator 862 and the body 851 of the actuator 850 can be such that an inner portion of the seals 865 forms a fluid tight seal with a surface of the actuator rod 862 and an outer portion of the seals 865 forms a fluid tight seal with an inner surface of the body 851 .
  • the seals 865 form one or more fluid tight seals between the actuator rod 862 and the inner surface of the body 851 .
  • the actuator rod 862 includes and/or is coupled to three seals 865 which form and/or define a first fluid flow path 833 within the body 851 of the actuator 850 and a second fluid flow path 854 within the body 851 of the actuator 850 .
  • the actuator rod 862 is configured to be moved or transitioned relative to the body 851 between a first position or configuration and a second position or configuration.
  • a force can be exerted on the first end portion 863 of the actuator rod 862 to place the actuator rod 862 in its first position and/or configuration, as shown in FIG. 23 .
  • the force exerted on the first end portion 863 of the actuator rod 862 can come from any suitable source.
  • a user can create the force with his or her hand or finger, a syringe, a positive or negative pressure source, and/or any other external energy source.
  • the inlet 852 of the actuator 850 When in the first position and/or configuration, the inlet 852 of the actuator 850 is in fluid communication with the first fluid flow path 833 and the outlet 853 of the actuator 850 is in fluid communication with the second fluid flow path 854 .
  • a force can be exerted on the second end portion 864 of the actuator rod 862 to place the actuator rod 862 in its second position and/or configuration, as shown in FIG. 24 .
  • the inlet 852 and the outlet 853 of the actuator 850 are each in fluid communication with the second fluid flow path 854 while the first fluid flow path is sequestered, isolated, and/or otherwise not in fluid communication with the inlet 852 and the outlet 853 .
  • the first port 858 of the actuator 850 is in fluid communication with the first fluid flow path 833 and the second port 859 of the actuator 850 is in fluid communication with the second fluid flow path 854 .
  • moving and/or transitioning the actuator rod 862 (or the actuator 850 in general) between the first position and the second position can be operable in selectively controlling a flow of fluid (e.g., bodily fluid) between the inlet 852 of the actuator 850 and the housing 830 , or between the inlet 852 of the actuator 850 and the outlet 853 of the actuator 850 , as described in further detail herein.
  • a flow of fluid e.g., bodily fluid
  • the device 800 can be used to procure a bodily fluid sample having reduced contamination from microbes such as, for example, dermally residing microbes, microbes external to the bodily fluid source, and/or the like.
  • a user such as a doctor, physician, nurse, phlebotomist, technician, etc. can manipulate the device 800 to establish fluid communication between the inlet 852 and the bodily fluid source (e.g., a vein of a patient).
  • the bodily fluid source e.g., a vein of a patient.
  • the outlet 853 can be fluidically coupled to the fluid collection device 880 .
  • the fluid collection device 880 can be, for example, a syringe (as shown in FIG. 25 ), and/or any other suitable container or device configured to define or produce a negative pressure or energy source.
  • coupling the outlet 853 to the fluid collection device 880 selectively exposes at least a portion of the control device 800 to a negative pressure within and/or produced by the fluid collection device 880 . More specifically, in the embodiment shown in FIGS. 19-25 , coupling the outlet 853 to the fluid collection device 880 exposes the outlet 853 of the actuator 850 and the second fluid flow path 854 to the negative pressure within and/or produced by the fluid collection device 880 .
  • the second port 859 of the actuator 850 is in fluid communication with the second fluid flow path 854 and the second port 846 of the housing 830 .
  • the second port 846 of the housing 830 is in selective fluid communication with the sequestration chamber 834 via the flow controller 842 and the restricted flow path 832 .
  • the device 800 and/or the flow controller 842 can be in a first operating state or mode in which the flow controller 842 allows a flow of gas (e.g., air) through the flow controller 842 while limiting and/or preventing a flow of liquid (e.g., bodily fluid such as blood) through the flow controller 842 .
  • a flow of gas e.g., air
  • liquid e.g., bodily fluid such as blood
  • control device 800 can be in a first or initial state when the flow controller 842 and/or the actuator 850 are in a first state, position, configuration, etc.
  • the actuator rod 862 can be in its first position and/or configuration in which the first fluid flow path 833 is in fluid communication with the inlet 852 .
  • the first port 858 of the actuator 850 and the first port 845 of the housing 830 establish fluid communication between the sequestration chamber 834 and the first fluid flow path 833 .
  • the negative pressure within the fluid collection device 880 can result in a negative pressure (or negative pressure differential) within at least a portion of the sequestration chamber 834 that is operable in drawing an initial flow, portion, amount, or volume of bodily fluid from the inlet 852 , through the first fluid flow path 833 , and into the sequestration chamber 834 when the actuator 850 and/or control device 800 is in the first or initial state (e.g., when the actuator rod 862 is in its first state, position, and/or configuration).
  • a negative pressure or negative pressure differential
  • the arrangement of the flow controller 842 and/or the restricted flow path 832 can be configured to restrict, limit, control, and/or otherwise modulate an amount or magnitude of negative pressure exerted on or through the sequestration chamber 834 , as described in detail above with reference to the device 200 .
  • the initial portion and/or amount of bodily fluid can be any suitable volume of bodily fluid, as described in detail above with reference to the control device 100 .
  • the initial volume can be associated with and/or at least partially based on an amount or volume of bodily fluid that is sufficient to fully wet or saturate the flow controller 842 .
  • the initial volume of bodily fluid can be a volume sufficient to transition the flow controller 842 from a first state to a second state (e.g., a saturated or fully wetted state).
  • the flow controller 842 is placed in a sealed configuration when transitioned to the second state.
  • the flow controller 842 e.g., the semi-permeable material
  • the flow controller 842 places the flow controller 842 in a sealed configuration in which the flow controller 842 substantially prevents a flow of a liquid and a gas therethrough.
  • transitioning the flow controller 842 to the second state sequesters, blocks, isolates, separates, segregates, and/or otherwise prevents flow through the flow controller 842 between the restricted flow path 832 and the sequestration chamber 834 .
  • the control device 800 and/or the actuator 850 can be transitioned to its second state or operating mode to sequester, segregate, retain, contain, isolate, etc. the initial volume in the sequestration chamber 834 .
  • the actuator 850 can be actuated to transition from its first state to its second state, for example, by exerting a force on the second end portion 864 of the actuator rod 862 .
  • the actuator rod 862 is moved and/or transitioned to its second state, position, and/or configuration in which the first fluid flow path 833 is sequestered and/or isolated from the inlet 852 .
  • the initial volume of bodily fluid is sequestered in the sequestration chamber 834 .
  • contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event, can be entrained and/or included in the initial volume of the bodily fluid and thus, are sequestered in the sequestration chamber 834 when the initial volume is sequestered therein.
  • moving and/or transitioning the control device 800 and/or the actuator 850 to its second state or configuration establishes fluid communication between the inlet 852 and the outlet 853 via the second fluid flow path 854 .
  • the negative pressure otherwise exerted on or through the sequestration chamber 834 is now exerted on or through the fluid flow path 854 .
  • bodily fluid can flow from the inlet 852 , through the fluid flow path 854 , through the outlet 853 , and into the fluid collection device 880 .
  • the arrangement of the control device 800 can be such that the control device 800 cannot transition to the second state prior to collecting and sequestering the initial volume in the sequestration chamber 834 , thereby reducing the likelihood of contaminants being transferred to the fluid collection device 880 .
  • the negative pressure source e.g., the fluid collection device 880 from the inlet 853 such as, for example, if it is desirable to collect multiple samples of bodily fluid using multiple fluid collection device 880 (e.g., syringes).
  • the user can engage the actuator 850 and exert a force on the first end portion 863 of the actuator rod 862 to move and/or transition the actuator rod 862 from its second position and/or configuration toward its first position and/or configuration.
  • the second fluid flow path 854 no longer places the inlet 852 in fluid communication with the outlet 853 .
  • the flow controller 842 can remain in the sealed state or configuration (e.g., fully saturated, wetted, and/or otherwise preventing flow therethrough) such that the outlet 853 is substantially sequestered or isolated from the rest of the control device 800 .
  • the user can then remove the filled fluid collection device 880 (e.g., syringe) and can couple a new fluid collection device 880 (e.g., syringe) to the outlet 853 .
  • the user can, for example, exert a force on the second end portion 864 of the actuator rod 862 to move and/or transition the actuator rod 862 back to its second position, state, and/or configuration, as described above.
  • FIG. 26 illustrates a fluid control device 900 .
  • the fluid control device 900 includes a housing 930 and an actuator 950 , which can be arranged, for example, in a modular configuration or the like.
  • the actuator 950 includes an inlet 952 configured to be placed in fluid communication with a bodily fluid source and an outlet 953 configured to be coupled to a fluid collection device 980 .
  • FIG. 26 illustrates a fluid control device 900 .
  • the fluid control device 900 includes a housing 930 and an actuator 950 , which can be arranged, for example, in a modular configuration or the like.
  • the actuator 950 includes an inlet 952 configured to be placed in fluid communication with a bodily fluid source and an outlet 953 configured to be coupled to a fluid collection device 980 .
  • the fluid collection device 980 is a transfer adapter configured to be coupled to one or more reservoirs such as, for example, an evacuated container, a sample bottle, a culture bottle, etc.
  • the reservoir can be sealed prior to being coupled to the transfer adapter (i.e., the fluid collection device 980 ) and once coupled the seal can be punctured, displaced, deformed, and/or otherwise unsealed to expose the outlet 953 to the negative pressure within the reservoir.
  • the fluid control device 900 can function in a substantially similar manner to the control device 800 described above with reference to FIGS. 19-25 .
  • a control device can include an actuator having any suitable configuration.
  • the fluid control device 900 includes an actuator rod 962 having only a single end portion that extends beyond the body 951 of the actuator 950 , as shown in FIG. 26 .
  • the device 900 can be used to fill a fluid collection device such as, for example, a sample reservoir, container, bottle, etc.
  • the user can, for example, decouple the inlet 952 from a lumen-containing device and/or any suitable device otherwise placing the inlet 952 in fluid communication with the bodily fluid source. Once decoupled, the user can couple the inlet of a new control device 900 to the lumen-containing device and/or the like and can collect one or more additional samples in a manner similar to that described above with reference to the control device 800 .
  • FIG. 27 illustrates a modular fluid control device 1000 according to an embodiment.
  • the fluid control device (also referred to herein as “device”) includes a housing 1030 forming and/or defining a sequestration chamber 1034 , and an actuator 1050 forming and/or having an inlet 1052 and an outlet 1053 .
  • the device 1000 can be substantially similar to the control device 800 described in detail above but can be arranged such that housing 1030 is disposed in different position and/or orientation relative to the actuator 1050 . In some embodiments, varying the arrangement may, for example, enhance usability, visibility, and/or the like and/or may otherwise allow for a more compact design.
  • FIG. 28 illustrates a modular fluid control device 1100 according to an embodiment.
  • the fluid control device (also referred to herein as “device”) includes a housing 1130 forming and/or defining a sequestration chamber 1134 , and an actuator 1150 forming and/or having an inlet 1152 and an outlet 1153 .
  • the device 1100 can be substantially similar to the control device 800 described in detail above but can be arranged such that housing 1130 is disposed in different position and/or orientation relative to the actuator 1150 .
  • the actuator 1150 can be arranged such that the inlet 1152 and the outlet 1153 are disposed in substantially perpendicular positions relative to one another.
  • varying the arrangement may, for example, enhance usability, visibility, and/or the like and/or may otherwise allow for a more compact design.
  • examples of modular fluid control devices are shown herein, it should be understood that such embodiments are presented by way of example and not limitation. Thus, while specific arrangements and/or orientations may be described herein, the devices and/or concepts described herein are not intended to be limited to those shown herein.
  • FIGS. 29-34 illustrate a fluid control device 1200 according to an embodiment.
  • the fluid control device 1200 can be similar in at least form and/or function to the fluid control devices described herein.
  • portions of the fluid control device 1200 can be similar to and/or substantially the same as corresponding portions of the fluid control devices 200 , 300 , 800 , 900 , 1000 , and/or 1100 described above. Accordingly, such portions of the fluid control device 1200 are not described in further detail herein.
  • the fluid control device 1200 (also referred to herein as “control device” or “device”) includes a housing 1230 and an actuator 1250 . As described above with reference to the control device 800 , the control device 1200 can be arranged in a modular configuration such that the housing 1230 and the actuator 1250 can be physically and fluidically coupled to form the control device 1200 . In other embodiments, the control device 1200 need not be modular. That is to say, in some embodiments, the control device 1200 can be assembled during manufacturing and delivered to a supplier and/or end user as an assembled device. In other embodiments, the control device can be monolithically formed and/or coupled to a fluid collection device in any suitable manner, as described in detail above.
  • the housing 1230 of the control device 1200 can be any suitable shape, size, and/or configuration.
  • the housing 1230 can be substantially similar in at least form and/or function to the housing 830 described in detail above. Accordingly, such similar portions of the housing 1230 are identified below but may not be described in further detail herein.
  • the housing 1230 forms and/or defines a sequestration chamber 1234 that is in selective fluid communication with a first port 1245 and a second port 1246 .
  • the second port 1246 is configured to receive, include, and/or define a flow controller 1242 (see e.g., FIG. 30 ) and a restricted flow path 1232 (see e.g., FIG. 31 ).
  • a housing need not include or receive a restricted flow path (e.g., when excessive negative pressure being applied to the sequestration chamber 1234 is unlikely or otherwise not intended such as when a fluid collection device is a syringe or the like).
  • the first port 1245 and the second port 1246 are configured to be at least fluidically coupled to a portion of the actuator 1250 to allow for selective fluid flow between the housing 1230 and the actuator 1250 .
  • the sequestration chamber 1234 is configured (1) to receive a selective flow and/or volume of bodily fluid from a portion of the actuator 1250 via the first port 1245 , and (2) to sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid (e.g., an initial or first flow and/or volume of bodily fluid or any portion thereof) within the sequestration chamber 1234 .
  • the sequestration chamber 1234 can have any suitable shape, size, and/or configuration.
  • the sequestration chamber 1234 can have any suitable size, volume, and/or fluid capacity such as, for example, those described above with reference to the sequestration chamber 134 .
  • the sequestration chamber 1234 can be, for example, a fluid flow path that extends through and/or that is defined by at least a portion of the housing 1230 .
  • the sequestration chamber 1234 can be substantially similar in at least form and/or function to the sequestration chamber 834 described above with reference to FIGS. 19-25 .
  • the sequestration chamber 1234 and/or the housing 1230 can differ from the sequestration chamber 834 and/or the housing 830 by being arranged in a spiral configuration with the first port 1245 being in fluid communication with, for example, an inner portion of the spiraled sequestration chamber 1234 and the second port 1246 being in fluid communication with, for example, an outer portion of the spiraled sequestration chamber, as shown in FIG. 30 .
  • the sequestration chamber 1234 can be, for example, a channel or the like formed in a portion of the housing 1230 .
  • the channel forming at least a portion of the sequestration chamber 1234 can have a relatively small cross-sectional shape and/or size that can reduce and/or substantially prevent a mixing of an initial volume of bodily fluid drawn into the sequestration chamber 1234 (channel) and a volume of air within the sequestration chamber 1234 (e.g., a volume of air that has not been vented or purged, as described in further detail herein).
  • the relatively small cross-sectional shape and/or size of the sequestration chamber 1234 (channel), a surface tension associated with the bodily fluid flowing into the sequestration chamber 1234 , and a contact angle between a surface of the housing 1230 forming the sequestration chamber 1234 and the bodily fluid flowing into the sequestration chamber 1234 can collectively limit and/or substantially prevent a mixing of the bodily fluid and a volume of air within the sequestration chamber 1234 .
  • the housing 1230 can include and/or can be coupled to a cover 1238 configured to enclose the channel, thereby forming the sequestration chamber 1234 .
  • the cover 1238 can be coupled to the housing 1230 in any suitable manner (e.g., via a friction fit, snap fit, interference fit, an adhesive, one or more mechanical fasteners, laser welding, ultrasonic welding, plasma techniques, annealing, heat boding and/or any other suitable coupling means or combination thereof).
  • the cover 1238 is monolithically formed with and/or coupled to the housing 1230 .
  • the cover 1238 can be at least partially transparent to allow a user to visualize a flow of bodily fluid through the sequestration chamber 1234 .
  • the arrangement of the housing 1230 and the cover 1238 can, for example, facilitate one or more manufacturing processes and/or can facilitate use of the control device 1200 .
  • the housing 1230 includes and/or defines a flow controller 1242 and a restricted flow path 1232 .
  • the flow controller 1242 can be, for example, a valve, membrane, diaphragm, restrictor, vent, a selectively permeable member, port, etc. configured to selectively control (at least in part) a flow of fluids into and/or out of the sequestration chamber 1234 and/or any other suitable portion of the housing 1230 .
  • the flow controller 1242 can be a selectively permeable fluid barrier (e.g., a blood barrier) that includes and/or is formed of a porous material configured to selectively allow a flow of gas therethrough but to prevent a flow of a liquid therethrough.
  • the flow controller 1242 can be configured to vent and/or purge a volume of air within the sequestration chamber 1234 through the flow controller 1242 in response to a negative pressure differential within a portion of the control device 1200 .
  • a venting and/or purging of the volume of air within the sequestration chamber 1234 can result in a suction force and/or negative pressure differential being exerted and/or applied in or on the sequestration chamber 1234 that is operable to draw in the initial volume of bodily fluid.
  • the use of a selectively permeable fluid barrier can allow for the venting and/or purging of air without allowing a volume of bodily fluid to pass through the flow controller 1242 .
  • the flow controller 1242 can be substantially similar to the flow controller 242 described in detail above with reference to FIGS. 2-5 and thus, is not described in further detail herein.
  • the actuator 1250 of the control device 1200 can be any suitable shape, size, and/or configuration.
  • the actuator 1250 can be substantially similar in at least form and/or function to the actuator 850 described in detail above. Accordingly, such similar portions of the actuator 1250 are identified below but may not be described in further detail herein.
  • the actuator 1250 includes a body 1251 and an actuator rod 1262 .
  • the body 1251 of the actuator 1250 includes an inlet 1252 and an outlet 1253 .
  • the inlet 1252 and the outlet 1253 can be substantially similar in at least form and/or function to the inlet 852 and the outlet 853 , respectively, described above with reference to FIGS. 19-25 .
  • the inlet 1252 is configured to be placed in fluid communication with a bodily fluid source to receive a flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle, IV catheter, PICC line, or the like).
  • the outlet 1253 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS.
  • a sample reservoir such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device, adapter, or vessel such as, for example, a transfer device similar to those described in the '510 publication.
  • a transfer device can provide a negative pressure and/or can act as an external energy source to enable desired functionality and fluid flow path dynamics/characteristics of the control device 1200 .
  • the body 1251 of the actuator 1250 includes and/or defines a first port 1258 and a second port 1259 .
  • the first port 1258 is in fluid communication with the inlet 1252 and the second port 1259 is in fluid communication with the outlet 1252 .
  • the first port 1258 and the second port 1259 are configured to be at least fluidically coupled to the first port 1245 and the second port 1246 , respectively, of the housing 1230 .
  • the arrangement of the ports 1258 and 1259 of the actuator 1250 and the ports 1245 and 1246 of the housing 1230 can allow for and/or otherwise can provide a means of physically coupling the housing 1230 to the actuator 1250 as well as fluidically coupling the housing 1230 to the actuator 1250 .
  • the arrangement of the ports 1258 and 1259 of the actuator 1250 and the ports 1245 and 1246 of the housing 1230 can allow for a modular configuration or arrangement as described above with reference to the control device 800 .
  • the housing 1230 and/or actuator 1250 need not be modular.
  • the body 1251 and the actuator rod 1262 collectively include and/or collectively form a lock configured to at least temporarily lock the actuator 1250 .
  • the body 1251 and the actuator rod 1262 can each define an opening 1257 in or through which a locking member can be disposed.
  • the locking member when the locking member (not shown in FIG. 32 ) is disposed in the openings 1257 , the locking member can limit and/or substantially prevent the actuator rod 1262 from being moved relative to the body 1251 .
  • removing the locking member from the openings 1257 can allow the actuator rod 1262 to be moved relative to the body 1251 .
  • the body 1251 and the actuator rod 1262 collectively include and/or collectively form a feature and/or arrangement that can limit and/or substantially prevent the actuator rod 1262 from being pulled out of the body 1251 .
  • the feature can be a snap, a lock, a catch, and/or any other suitable feature and/or arrangement.
  • a portion of the actuator rod 1262 includes and/or is coupled to a set of seals 1265 .
  • the seals 1265 can be, for example, o-rings, over-molded elastomeric material, raised protrusions, and/or the like.
  • the arrangement of the actuator 1262 and the body 1251 of the actuator 1250 can be such that the seals 1265 form one or more fluid tight seals between the actuator rod 1262 and the inner surface of the body 1251 , as described above with reference to the actuator 850 . In the embodiment shown in FIGS.
  • the actuator rod 1262 includes and/or is coupled to three seals 1265 which form and/or define a first fluid flow path 1233 within the body 1251 of the actuator 1250 and a second fluid flow path 1254 within the body 1251 of the actuator 1250 .
  • any number of seals may be used to achieve desired performance.
  • the device 1200 can be used to procure a bodily fluid sample having reduced contamination from microbes such as, for example, dermally residing microbes, microbes external to the bodily fluid source, and/or the like.
  • the actuator rod 1262 is configured to be moved or transitioned relative to the body 1251 between a first position or configuration and a second position or configuration.
  • the transition of the actuator rod 1262 can be achieved by and/or can otherwise result from user interaction and manipulation of the actuator rod 1262 , automatically in response to negative pressure and associated flow dynamics within the device 1200 , and/or enacted by or in response to an external energy source which creates dynamics that result in the transitioning of the actuator rod 1262 .
  • the inlet 1252 of the actuator 1250 when in the first position and/or configuration, is in fluid communication with the first fluid flow path 1233 , which in turn, is in fluid communication with the first port 1258 .
  • the outlet 1253 of the actuator 1250 is in fluid communication with the second fluid flow path 1254 , which in turn, is in fluid communication with the second port 1259 .
  • the negative pressure within the fluid collection device not shown in FIGS.
  • 29-34 can result in a negative pressure (or negative pressure differential) within at least a portion of the sequestration chamber 1234 that is operable in drawing at least a portion of an initial flow, amount, or volume of bodily fluid from the inlet 1252 , through the first fluid flow path 1233 , and into the sequestration chamber 1234 .
  • the initial volume and/or flow of bodily fluid can be transferred into the sequestration chamber 1234 until, for example, the bodily fluid disposed within the sequestration chamber 1234 transitions the flow controller 1242 from an open or unsealed configuration or state (e.g., one in which a flow of gas or air can be drawn therethrough) to a sealed configuration or state (e.g., one in which a flow of gas and liquid cannot be drawn therethrough).
  • an open or unsealed configuration or state e.g., one in which a flow of gas or air can be drawn therethrough
  • a sealed configuration or state e.g., one in which a flow of gas and liquid cannot be drawn therethrough.
  • a force can be exerted on the end portion 1263 of the actuator rod 1262 to place the actuator rod 1262 and/or actuator 1250 in its second position and/or configuration, as shown in FIG. 34 .
  • the actuator 1250 may be transitioned from a locked configuration or state to an unlocked configuration or state.
  • the inlet 1252 and the outlet 1253 of the actuator 1250 are each in fluid communication with the second fluid flow path 1254 while the first fluid flow path 1233 is sequestered, isolated, and/or otherwise not in fluid communication with the inlet 1252 and the outlet 1253 .
  • contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event or throughout the bodily fluid collection process, can be entrained and/or included in the initial volume of the bodily fluid and thus, are sequestered in the sequestration chamber 1234 when the initial volume is sequestered therein.
  • the negative pressure otherwise exerted on or through the sequestration chamber 1234 is now exerted on or through the second fluid flow path 1254 .
  • bodily fluid can flow from the inlet 1252 , through the second fluid flow path 1254 , through the outlet 1253 , and into the fluid collection device coupled to the outlet 1253 .
  • the device 1200 can function in a manner substantially similar to that of the device 800 and thus, the function of the device 1200 is not described in further detail herein.
  • FIGS. 35-40 illustrate a fluid control device 1300 according to an embodiment.
  • the fluid control device 1300 can be similar in at least form and/or function to the fluid control devices described herein. More specifically, portions of the fluid control device 1300 can be similar to and/or substantially the same as corresponding portions of the fluid control devices 200 , 300 , 800 , 900 , 1000 , 1100 , and/or 1200 described above. Accordingly, such portions of the fluid control device 1300 are not described in further detail herein.
  • the fluid control device 1300 (also referred to herein as “control device” or “device”) includes a housing 1330 and an actuator 1350 . As described above with reference to the control devices 800 , the control device 1300 can be arranged in a modular configuration such that the housing 1330 and the actuator 1350 can be physically and fluidically coupled to form the control device 1300 . In other embodiments, the control device 1300 need not be modular. That is to say, in some embodiments, the control device 1300 can be assembled during manufacturing and delivered to a supplier and/or end user as an assembled device. In other embodiments, the device 1300 can be monolithically formed and/or collectively formed with, for example, a fluid collection device, as described above.
  • the housing 1330 of the control device 1300 can be any suitable shape, size, and/or configuration. As shown in FIGS. 35-37 , the housing 1330 forms and/or defines a sequestration chamber 1334 that is in selective fluid communication with a first port 1345 and a second port 1346 .
  • the second port 1346 is configured to receive, include, and/or define a flow controller 1342 (see e.g., FIG. 36 ) and a restricted flow path 1332 (see e.g., FIG. 37 ).
  • the first port 1345 and the second port 1346 are configured to be at least fluidically coupled to a portion of the actuator 1350 to allow for selective fluid flow between the housing 1330 and the actuator 1350 .
  • the sequestration chamber 1334 is configured (1) to receive a selective flow and/or volume of bodily fluid from a portion of the actuator 1350 via the first port 1345 , and (2) to sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid (e.g., at least a portion of an initial or first flow and/or volume of bodily fluid) within the sequestration chamber 1334 .
  • the sequestration chamber 1334 can have any suitable shape, size, and/or configuration.
  • the sequestration chamber 1334 can be, for example, a channel or the like formed in a portion of the housing 1330 and the housing 1330 can include and/or can be coupled to a cover 1338 configured to enclose the channel, thereby forming the sequestration chamber 1334 .
  • the housing 1330 can be substantially similar in at least form and/or function to the housing 1230 described in detail above with reference to FIGS. 29-34 . Accordingly, the housing 1330 is not described in further detail herein.
  • the actuator 1350 of the control device 1300 can be any suitable shape, size, and/or configuration.
  • the actuator 1350 can be substantially similar in at least form and/or function to the actuators 850 and/or 1250 described in detail above. Accordingly, such similar portions of the actuator 1350 are identified below but may not be described in further detail herein.
  • the actuator 1350 includes a body 1351 and an actuator rod 1362 .
  • the body 1351 of the actuator 1350 includes an inlet 1352 and an outlet 1353 .
  • the inlet 1352 and the outlet 1353 can be substantially similar in at least form and/or function to the inlet 852 and the outlet 853 , respectively, described above with reference to FIGS. 19-25 .
  • the inlet 1352 is configured to be placed in fluid communication with a bodily fluid source to receive a flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle, IV catheter, surgical tubing, other standard bodily-fluid transfer device, PICC line, or the like).
  • the outlet 1353 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS. 35-40 ) such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device, adapter, or vessel such as, for example, a transfer device similar to those described in the '510 publication.
  • a fluid collection device such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device, adapter, or vessel such as, for example, a transfer device similar to those described in the '510 publication.
  • the body 1351 of the actuator 1350 includes and/or defines a first port 1358 and a second port 1359 .
  • the first port 1358 is in fluid communication with the inlet 1352 and the second port 1359 is in fluid communication with the outlet 1353 .
  • the first port 1358 and the second port 1359 are configured to be at least fluidically coupled to the first port 1345 and the second port 1346 , respectively, of the housing 1330 .
  • the arrangement of the ports 1358 and 1359 of the actuator 1350 and the ports 1345 and 1346 of the housing 1330 can allow for and/or otherwise can provide a means of physically coupling the housing 1330 to the actuator 1350 as well as fluidically coupling the housing 1330 to the actuator 1350 .
  • the arrangement of the ports 1358 and 1359 of the actuator 1350 and the ports 1345 and 1346 of the housing 1330 can allow for a modular configuration or arrangement as described above with reference to the control device 800 .
  • the housing 1330 and/or actuator 1350 need not be modular.
  • a portion of the actuator rod 1362 includes and/or is coupled to a set of seals 1365 .
  • the seals 1365 can be, for example, o-rings, elastomeric material, silicone or any other suitable material or configuration as described above with reference to the seals 1265 .
  • the arrangement of the actuator 1362 and the body 1351 of the actuator 1350 can be such that the seals 1365 form one or more fluid tight seals between the actuator rod 1362 and the inner surface of the body 1351 , as described above with reference to the actuator 850 . In the embodiment shown in FIGS.
  • the actuator rod 1362 includes and/or is coupled to three seals 1365 which form and/or define a first fluid flow path 1333 within the body 1351 of the actuator 1350 and a second fluid flow path 1354 within the body 1351 of the actuator 1350 .
  • the device 1300 can be used to procure a bodily fluid sample having reduced contamination from microbes such as, for example, dermally residing microbes, microbes external to the bodily fluid source, and/or the like.
  • the actuator rod 1362 is configured to be moved or transitioned relative to the body 1351 between a first position or configuration and a second position or configuration. As shown in FIG. 39 , when in the first position and/or configuration, the inlet 1352 of the actuator 1350 is in fluid communication with the first fluid flow path 1333 , which in turn, is in fluid communication with the first port 1358 .
  • the outlet 1353 of the actuator 1350 is in fluid communication with the second fluid flow path 1354 , which in turn, is in fluid communication with the second port 1359 .
  • the negative pressure within the fluid collection device (not shown in FIGS. 35-40 ) can result in a negative pressure (or negative pressure differential) within at least a portion of the sequestration chamber 1334 that is operable in drawing at least a portion of an initial flow, amount, or volume of bodily fluid from the inlet 1352 , through the first fluid flow path 1333 , and into the sequestration chamber 1334 .
  • the initial volume and/or flow of bodily fluid can be transferred into the sequestration chamber 1334 until, for example, the bodily fluid disposed within the sequestration chamber 1334 transitions the flow controller 1342 from an open or unsealed configuration or state (e.g., one in which a flow of gas or air can be drawn therethrough) to a sealed configuration or state (e.g., one in which a flow of gas and liquid cannot be drawn therethrough).
  • an open or unsealed configuration or state e.g., one in which a flow of gas or air can be drawn therethrough
  • a sealed configuration or state e.g., one in which a flow of gas and liquid cannot be drawn therethrough.
  • a force can be exerted on a first end portion 1363 of the actuator rod 1362 to place the actuator rod 1362 and/or actuator 1350 in its second position, state, operating mode, and/or configuration, as shown in FIG. 35 .
  • the actuator 1350 may be transitioned from a locked configuration or state to an unlocked configuration or state.
  • the transition of the actuator rod 1362 can be achieved by and/or can otherwise result from user interaction and manipulation of the actuator rod 1362 , automatically in response to negative pressure and associated flow dynamics within the device 1300 , and/or enacted by or in response to an external energy source which creates dynamics that result in the transitioning of the actuator rod 1362 .
  • the inlet 1352 and the outlet 1353 of the actuator 1350 are each in fluid communication with the second fluid flow path 1354 while the first fluid flow path 1333 is sequestered, isolated, and/or otherwise not in fluid communication with the inlet 1352 and the outlet 1353 .
  • contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event or throughout the bodily-fluid collection process, can be entrained and/or included in the initial volume of the bodily fluid and thus, are sequestered in the sequestration chamber 1334 when the initial volume is sequestered therein.
  • the negative pressure otherwise exerted on or through the sequestration chamber 1334 is now exerted on or through the second fluid flow path 1354 .
  • bodily fluid can flow from the inlet 1352 , through the second fluid flow path 1354 , through the outlet 1353 , and into the fluid collection device coupled to the outlet 1353 .
  • the device 1300 can function in a manner substantially similar to that of the device 800 and thus, the function of the device 1300 is not described in further detail herein.
  • the negative pressure source e.g., the fluid collection device from the inlet 1353 such as, for example, if it is desirable to collect multiple samples of bodily fluid using multiple fluid collection devices (e.g., syringes or the like).
  • the user can engage the actuator 1350 and exert a force on a second end portion 1364 of the actuator rod 1362 to move and/or transition the actuator rod 1362 from its second position and/or configuration toward its first position and/or configuration.
  • the second fluid flow path 1354 no longer places the inlet 1352 in fluid communication with the outlet 1353 .
  • the flow controller 1342 can remain in the sealed state or configuration (e.g., fully saturated, wetted, and/or otherwise preventing flow therethrough) such that the outlet 1353 is substantially sequestered or isolated from the rest of the control device 1300 .
  • the user can then remove the filled fluid collection device and can couple a new fluid collection device to the outlet 1353 .
  • the new fluid collection device coupled to the outlet 1353 , the user can, for example, exert a force on the first end portion 1363 of the actuator rod 1362 to move and/or transition the actuator rod 1362 back to its second position, state, and/or configuration, as described above with reference to the actuator 850 .
  • FIGS. 41-44 illustrate a fluid control device 1400 according to an embodiment.
  • the fluid control device 1400 can be similar in at least form and/or function to the fluid control devices described herein. More specifically, portions of the fluid control device 1400 can be similar to and/or substantially the same as corresponding portions of the fluid control devices 200 , 300 , 800 , 900 , 1000 , 1100 , 1200 , and/or 1300 described above. Accordingly, such portions of the fluid control device 1400 are not described in further detail herein.
  • the fluid control device 1400 (also referred to herein as “control device” or “device”) includes a housing 1430 and an actuator 1450 . As described above with reference to the control device 800 , the control device 1400 can be arranged in a modular configuration such that the housing 1430 and the actuator 1450 can be physically and fluidically coupled to form the control device 1400 . In other embodiments, the control device 1400 need not be modular. That is to say, in some embodiments, the control device 1400 can be assembled during manufacturing and delivered to a supplier and/or end user as an assembled device. In other embodiments, the device 1400 can be monolithically formed and/or collectively formed with, for example, a fluid collection device, as described above.
  • the housing 1430 of the control device 1400 can be any suitable shape, size, and/or configuration.
  • the housing 1430 is configured to be in selective fluid communication with a portion of the actuator 1450 via a first port 1458 and a second port 1459 .
  • the housing 1430 includes a bladder 1478 that can be transitioned from a first configuration and/or state to a second configuration and/or state to form and/or define a sequestration chamber 1434 .
  • the bladder 1478 is configured to transition from the first configuration and/or state ( FIG. 43 ) to the second configuration and/or state ( FIG.
  • the sequestration chamber 1434 can sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid (e.g., at least a portion of an initial or first flow and/or volume of bodily fluid) within the sequestration chamber 1434 .
  • sequester e.g., separate, segregate, contain, retain, isolate, etc.
  • bodily fluid e.g., at least a portion of an initial or first flow and/or volume of bodily fluid
  • the bladder 1478 is particularly shown in FIGS. 43 and 44 , in other embodiments, the bladder 1478 can be any suitable shape, size, and/or configuration. Similarly, the bladder 1478 can be formed of any suitable material (e.g., any suitable biocompatible material such as those described herein and/or any other suitable material). In some embodiments, the bladder 1478 can be arranged and/or configured as, for example, a bellows, an expandable bag, a flexible pouch, and/or any other suitable reconfigurable container or the like. In addition, the sequestration chamber 1434 formed by the bladder 1478 can have any suitable shape, size, and/or configuration.
  • the housing 1430 can be substantially similar in at least form and/or function to the housing 1230 and/or 1330 described in detail above with reference to FIGS. 29-34 and FIGS. 35-40 , respectively. Accordingly, the housing 1430 is not described in further detail herein.
  • the actuator 1450 of the control device 1400 can be any suitable shape, size, and/or configuration.
  • the actuator 1450 can be substantially similar in at least form and/or function to the actuators 850 , 1250 , and/or 1350 described in detail above. Accordingly, such similar portions of the actuator 1450 are identified below but may not be described in further detail herein.
  • the actuator 1450 includes a body 1451 and an actuator rod 1462 .
  • the body 1451 of the actuator 1450 includes an inlet 1452 and an outlet 1453 .
  • the inlet 1452 and the outlet 1453 can be substantially similar in at least form and/or function to the inlet 1252 and the outlet 1253 , respectively, described above with reference to FIGS. 29-34 .
  • the inlet 1452 is configured to be placed in fluid communication with a bodily fluid source to receive a flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle, IV catheter, surgical tubing, other standard bodily-fluid transfer device, PICC line, or the like).
  • the outlet 1453 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS. 41-44 ) such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device, adapter, or vessel such as, for example, a transfer device similar to those described in the '510 publication.
  • a fluid collection device such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device, adapter, or vessel such as, for example, a transfer device similar to those described in the '510 publication.
  • the body 1451 of the actuator 1450 includes and/or defines the first port 1458 and the second port 1459 .
  • the first port 1458 is configured to be in fluid communication with the inlet 1452 and the second port 1459 is configured to be in fluid communication with the outlet 1453 .
  • the first port 1458 is configured to be in fluid communication with the housing 1430 and more particularly, an inner volume or an inlet side of the bladder 1478 that forms the sequestration chamber 1434 .
  • the second port 1459 is configured to be in fluid communication with a portion of the housing 1430 defined between an inner surface of the housing 1430 and an outer surface of the bladder 1478 .
  • the second port 1459 is in fluid communication with a portion of the housing 1430 that is isolated and/or sequestered from the inner volume of the bladder 1478 that forms the sequestration chamber 1434 .
  • the arrangement of the ports 1458 and 1459 of the actuator 1450 can allow for and/or otherwise can provide a means of physically coupling the housing 1430 to the actuator 1450 as well as fluidically coupling the housing 1430 to the actuator 1450 . That is to say, in some embodiments, the arrangement of the ports 1458 and 1459 of the actuator 1450 can allow for a modular configuration or arrangement as described above with reference to the control device 800 . In other embodiments, the housing 1430 and/or actuator 1450 need not be modular.
  • a portion of the actuator rod 1462 includes and/or is coupled to a set of seals.
  • the seals can be, for example, o-rings, elastomeric material, silicone or any other suitable material or configuration as described above with reference to the seals 1265 and/or 1365 .
  • the arrangement of the actuator rod 1462 and the body 1451 of the actuator 1450 can be such that the seals form one or more fluid tight seals between the actuator rod 1462 and the inner surface of the body 1451 , as described above with reference to the actuators 850 , 1250 , and/or 1350 .
  • the actuator rod 1462 can include and/or can be coupled to a set seals which selectively form and/or define a first fluid flow path configured to place the inlet 1452 of the actuator 1450 in fluid communication with the first port 1458 (e.g., when in a first position, state, operating mode, and/or configuration) and a second fluid flow path configured to place the inlet 1452 in fluid communication with the outlet 1453 (e.g., when in a second position, state, operating mode, and/or configuration).
  • the device 1400 can be used to procure a bodily fluid sample having reduced contamination from microbes such as, for example, dermally residing microbes, microbes external to the bodily fluid source, and/or the like.
  • the actuator rod 1462 can be configured to be moved or transitioned relative to the body 1451 between a first position or configuration and a second position or configuration.
  • the inlet 1452 of the actuator 1450 is in fluid communication with, for example, the first fluid flow path, which in turn, is in fluid communication with the first port 1458 (not shown in FIGS.
  • the outlet 1453 of the actuator 1450 is in fluid communication with the second fluid flow path 1454 , which in turn, is in fluid communication with the second port 1459 .
  • the negative pressure within the fluid collection device (not shown in FIGS. 41-44 ) can result in a negative pressure (or negative pressure differential) within the portion of the housing 1430 defined between the inner surface of the housing 1430 and the outer surface of the bladder 1478 .
  • the bladder 1478 can be in a first state and/or configuration prior to the fluid collection device being coupled to the outlet 1453 .
  • the bladder 1478 can have a flipped, inverted, collapsed, and/or empty configuration prior to coupling the fluid collection device to the outlet 1453 .
  • the bladder 1478 can be configured to transition from the first state and/or configuration to a second state and/or configuration in response to the negative pressure differential resulting from the coupling of the fluid collection device to the outlet 1453 .
  • the negative pressure differential can be operable to transition the bladder 1478 from a collapsed or unexpanded configuration and/or state to an expanded configuration and/or state.
  • the transitioning of the bladder 1478 can be similar to the transitioning and/or “flipping” of the diaphragm 576 , described above with reference to FIGS. 11 and 12 .
  • the bladder 1478 can be configured to transition from the first configuration and/or state to the second configuration and/or state to form and/or define the sequestration chamber 1434 .
  • the transitioning of the bladder 1478 results in an increase in an inner volume of the bladder 1478 (i.e., the sequestration chamber 1434 ).
  • the increase in the inner volume can, in turn, result in a negative pressure differential between the sequestration chamber 1434 defined by the bladder 1478 and the inlet 1452 that is operable in drawing at least a portion of an initial flow, amount, or volume of bodily fluid from the inlet 1452 , through the first port 1458 , and into the sequestration chamber 1434 .
  • the initial volume and/or flow of bodily fluid can be transferred into the sequestration chamber 1434 until, for example, the bladder 1478 is fully expanded, and/or until the negative pressure differential is reduced and/or equalized.
  • a force can be exerted on a first end portion 1463 of the actuator rod 1462 to place the actuator rod 1462 and/or actuator 1450 in its second position, state, operating mode, and/or configuration, as described in detail above with reference to the devices 1200 and/or 1300 .
  • the actuator 1450 may be transitioned from a locked configuration or state to an unlocked configuration or state.
  • the transition of the actuator rod 1462 can be achieved by and/or can otherwise result from user interaction and manipulation of the actuator rod 1462 , automatically in response to negative pressure and associated flow dynamics within the device 1400 , and/or enacted by or in response to an external energy source which creates dynamics that result in the transitioning of the actuator rod 1462 .
  • the inlet 1452 and the outlet 1453 of the actuator 1450 are placed in fluid communication (e.g., via the second fluid flow path (not shown)) while the first fluid flow path (not shown) and/or the first port 1458 is sequestered, isolated, and/or otherwise not in fluid communication with the inlet 1452 and/or the outlet 1453 .
  • contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event or throughout the bodily-fluid collection process, can be entrained and/or included in the initial volume of the bodily fluid and thus, are sequestered in the sequestration chamber 1434 when the initial volume is sequestered therein.
  • the negative pressure otherwise exerted on or through the housing 1430 is now exerted on or through the outlet 1453 and the inlet 1452 via, for example, the second fluid flow path (not shown).
  • bodily fluid can flow from the inlet 1452 , through the body 1451 of the actuator 1450 , through the outlet 1453 , and into the fluid collection device coupled to the outlet 1453 .
  • the device 1400 can function in a manner substantially similar to that of the devices 800 , 1200 , and/or 1300 and thus, the function of the device 1400 is not described in further detail herein.
  • FIGS. 45-50 illustrate a fluid control device 1500 according to an embodiment.
  • the fluid control device 1500 can be similar in at least form and/or function to the fluid control devices described herein. More specifically, portions of the fluid control device 1500 can be similar to and/or substantially the same as corresponding portions of at least the fluid control device 1400 described above with reference to FIGS. 41-44 . Accordingly, such portions of the fluid control device 1500 are not described in further detail herein.
  • the fluid control device 1500 (also referred to herein as “control device” or “device”) includes an actuator 1550 having an actuator body 1551 and an actuator rod 1562 .
  • the actuator 1550 can be any suitable shape, size, and/or configuration.
  • the actuator 1550 can be substantially similar in at least form and/or function to the actuators 850 , 1250 , 1350 , and/or 1450 described in detail above. Accordingly, such similar portions of the actuator 1550 are identified below but may not be described in further detail herein.
  • the actuator 1550 includes an inlet 1552 and an outlet 1553 , each of which is in fluid communication with the body 1551 .
  • the inlet 1552 and the outlet 1553 can be substantially similar in at least form and/or function to the inlet 1252 and the outlet 1253 , respectively, described above with reference to FIGS. 29-34 .
  • the inlet 1552 is configured to be placed in fluid communication with a bodily fluid source to receive a flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle, IV catheter, surgical tubing, other standard bodily-fluid transfer device, PICC line, or the like).
  • the outlet 1553 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS. 45-50 ) such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device, adapter, or vessel such as, for example, a transfer device similar to those described in the '510 publication.
  • a fluid collection device such as, for example, a sample reservoir, a syringe, and/or other intermediary bodily fluid transfer device, adapter, or vessel such as, for example, a transfer device similar to those described in the '510 publication.
  • the actuator 1550 includes a bladder 1578 that can be transitioned from a first configuration and/or state ( FIG. 48 ) to a second configuration and/or state ( FIG. 49 ) to form and/or define a sequestration chamber 1534 .
  • the bladder 1578 is configured to transition from the first configuration and/or state ( FIG. 48 ) to the second configuration and/or state ( FIGS. 49 and 50 ) to form and/or define the sequestration chamber 1534 , which in turn, is configured to receive a selective flow and/or volume of bodily fluid from the inlet 1552 .
  • the sequestration chamber 1534 can sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid (e.g., at least a portion of an initial or first flow and/or volume of bodily fluid) within the sequestration chamber 1534 .
  • the bladder 1578 can be substantially similar in at least form and/or function to the bladder 1478 described above with reference to FIGS. 41-44 and thus, is not described in further detail herein.
  • the body 1551 of the actuator 1550 includes and/or defines a port 1559 configured to be in fluid communication with the outlet 1553 .
  • the port 1559 defines a fluid flow path that is configured to be in fluid communication with a portion of the actuator 1550 defined between an inner surface of the body 1551 and an outer surface of the bladder 1578 .
  • the port 1559 is in fluid communication with a portion of the actuator 1550 that is isolated and/or sequestered from the inner volume of the bladder 1578 that forms and/or that is configured to form the sequestration chamber 1534 .
  • a portion of the actuator rod 1562 includes and/or is coupled to a set of seals 1565 .
  • the seals 1565 can be, for example, o-rings, elastomeric material, silicone or any other suitable material or configuration as described above with reference to the seals 1265 and/or 1365 .
  • the arrangement of the actuator rod 1562 and the body 1551 of the actuator 1550 can be such that the seals 1565 form one or more fluid tight seals between the actuator rod 1562 and the inner surface of the body 1551 , as described above with reference to the actuators 850 , 1250 , and/or 1350 .
  • the set seals 1565 can be arranged along the actuator rod 1562 to selectively form and/or define a fluid flow path 1554 that is sequestered from and/or fluidically isolated from the inlet 1552 when the actuator rod 1562 is in a first position and/or configuration and that is configured to place the inlet 1552 in fluid communication with the outlet 1553 when the actuator rod 1562 is in a second position and/or configuration.
  • the device 1500 can be used to procure a bodily fluid sample having reduced contamination from microbes such as, for example, dermally residing microbes, microbes external to the bodily fluid source, and/or the like.
  • the actuator rod 1562 can be configured to be moved or transitioned relative to the body 1551 between the first position or configuration and the second position or configuration.
  • the inlet 1552 of the actuator 1550 When in the first position and/or configuration, the inlet 1552 of the actuator 1550 is in fluid communication with a fluid flow path, which in turn, is in fluid communication with a portion of the body 1551 that is disposed on an inlet side of the bladder 1578 .
  • the fluid flow path establishes fluid communication between the inlet 1553 and the bladder 1578 and/or the sequestration chamber 1534 at least partially defined by the bladder 1578 when the bladder 1578 is transitioned to the second configuration and/or state.
  • the outlet 1553 of the actuator 1550 is in fluid communication with the port 1559 .
  • the negative pressure within the fluid collection device can result in a negative pressure (or negative pressure differential) within the portion of the actuator body 1551 defined between the inner surface of the body 1551 and the outer surface of the bladder 1578 , as described above with reference to the device 1400 .
  • the bladder 1578 can be in a first state and/or configuration prior to the fluid collection device being coupled to the outlet 1553 .
  • the bladder 1578 can have a flipped, inverted, collapsed, and/or empty configuration prior to coupling the fluid collection device to the outlet 1553 .
  • the actuator rod 1562 when the actuator rod 1562 is in the first position and/or configuration, the fluid flow path 1554 is fluidically isolated from the inlet 1552 .
  • the bladder 1578 can be configured to transition from the first state and/or configuration to a second state and/or configuration in response to the negative pressure differential resulting from the coupling of the fluid collection device to the outlet 1553 .
  • the negative pressure differential can be operable to transition the bladder 1578 from a collapsed or unexpanded configuration and/or state to an expanded configuration and/or state.
  • the transitioning of the bladder 1578 can be similar to the transitioning and/or “flipping” of the diaphragm 576 , described above with reference to FIGS. 11 and 12 .
  • the bladder 1578 can be configured to transition between a first state and/or configuration to a second state and/or configuration in any suitable manner such as any of those described herein.
  • the bladder 1578 can be configured to transition from the first configuration and/or state to the second configuration and/or state to form and/or define the sequestration chamber 1534 .
  • the transitioning of the bladder 1578 results in an increase in an inner volume of the bladder 1578 (i.e., the sequestration chamber 1534 ).
  • the increase in the inner volume can, in turn, result in a negative pressure differential between the sequestration chamber 1534 defined by the bladder 1578 and the inlet 1552 that is operable in drawing at least a portion of an initial flow, amount, or volume of bodily fluid from the inlet 1552 and a portion of the actuator body 1551 , and into the sequestration chamber 1534 .
  • the initial volume and/or flow of bodily fluid can be transferred into the sequestration chamber 1534 until, for example, the bladder 1578 is fully expanded, and/or until the negative pressure differential is reduced and/or equalized.
  • a force can be exerted on a first end portion 1563 of the actuator rod 1562 to place the actuator rod 1562 and/or actuator 1550 in its second position, state, operating mode, and/or configuration, as described in detail above with reference to the devices 1200 and/or 1300 .
  • the actuator 1550 may be transitioned from a locked configuration or state to an unlocked configuration or state.
  • the transition of the actuator rod 1562 can be achieved by and/or can otherwise result from user interaction and manipulation of the actuator rod 1562 , automatically in response to negative pressure and associated flow dynamics within the device 1500 , and/or enacted by or in response to an external energy source which creates dynamics that result in the transitioning of the actuator rod 1562 .
  • the inlet 1552 and the outlet 1553 of the actuator 1550 are placed in fluid communication via the fluid flow path 1554 while the sequestration chamber 1534 is sequestered, isolated, and/or otherwise not in fluid communication with the inlet 1552 and/or the outlet 1553 .
  • contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event or throughout the bodily-fluid collection process, can be entrained and/or included in the initial volume of the bodily fluid and thus, are sequestered in the sequestration chamber 1534 when the initial volume is sequestered therein.
  • transitioning the actuator rod 1562 to the second position and/or configuration is such that the fluid flow path 1554 places the inlet 1552 in fluid communication with the outlet 1553 .
  • transitioning the actuator rod 1562 to the second position and/or configuration can move the seals 1565 relative to the inlet 1552 such that the fluid flow path 1554 is placed in fluid communication with both the inlet 1552 and the outlet 1553 .
  • the negative pressure otherwise exerted on the outer surface of the bladder 1578 is now exerted on or through the outlet 1553 and the inlet 1552 via the fluid flow path 1554 .
  • bodily fluid can flow from the inlet 1552 , through the fluid flow path 1554 , through the outlet 1553 , and into the fluid collection device coupled to the outlet 1553 .
  • the device 1500 can function in a manner substantially similar to that of the devices 800 , 1200 , 1300 , and/or 1400 and thus, the function of the device 1500 is not described in further detail herein.
  • a fluid control device can include one or more actuators that can be transitioned in response to any suitable force, input, change of state or configuration, etc.
  • FIGS. 51 and 52 illustrate a portion of a fluid control device 1600 according to an embodiment.
  • the fluid control device 1600 can be similar in at least form and/or function to the fluid control devices described herein. More specifically, portions of the fluid control device 1600 can be similar to and/or substantially the same as corresponding portions of at least the fluid control devices 500 , 600 , and/or 700 described above. Accordingly, such portions of the fluid control device 1600 are not described in further detail herein.
  • the fluid control device 1600 (also referred to herein as “control device” or “device”) includes a housing 1630 having an inlet 1631 and an outlet 1636 , and having and/or being coupled to an actuator 1650 .
  • the housing 1630 defines a set of fluid flow paths 1633 and 1654 configured to establish fluid communication between one or more portions of the housing 1630 to selectively receive a flow of fluid therethrough (e.g., a liquid and/or a gas).
  • the inlet 1631 is configured to be placed in fluid communication with a bodily fluid source to receive a flow of bodily fluid therefrom (e.g., via a lumen-containing device such as a needle or the like, as described in detail above).
  • the outlet 1636 is configured to be fluidically coupled to a fluid collection device (not shown in FIGS. 51 and 52 ).
  • the inlet 1631 , the outlet 1636 , and the fluid collection device can be substantially similar to those described above and thus, are not described in further detail herein.
  • the housing 1630 can be any suitable shape, size, and/or configuration. In some embodiments, the housing 1630 can have a size that is at least partially based on a volume of bodily fluid configured to be at least temporarily stored within one or more portions of the housing 1630 . As described above, the housing 1630 of the control device 1600 is configured to (1) receive a flow and/or volume of bodily fluid via the inlet 1631 and (2) sequester (e.g., separate, segregate, contain, retain, isolate, etc.) the flow and/or volume of bodily fluid within a sequestration chamber 1634 included in and/or at least partially formed by the housing 1630 . In some embodiments, aspects of the housing 1630 can be substantially similar, for example, to aspects of the housings 630 , 730 , and/or 830 . Accordingly, some portions and/or aspects of the housing 1630 are not described in further detail herein.
  • the housing 1630 includes and/or is coupled to the actuator 1650 configured to selectively control a flow of bodily fluid through the housing 1630 .
  • the actuator 1650 includes a diaphragm 1676 and an actuator rod 1662 having a set of seals (e.g., seals 1665 and 1666 ).
  • the diaphragm 1676 and the actuator rod 1662 are configured to transition, move, and/or otherwise reconfigure within the housing 1630 in response to a negative pressure differential within at least a portion of the device.
  • the actuator 1650 is configured to move between a first state in which the inlet 1631 is placed in fluid communication with the sequestration chamber 1634 and a second state in which the inlet 1631 is placed in fluid communication with the outlet 1636 via the fluid flow path 1654 , as described in detail above with reference to the control device 500 .
  • the diaphragm 1676 can be similar to, for example, the diaphragms 576 , 676 , and/or 776 described in detail above. Accordingly, the diaphragm 1676 can be at least partially disposed in a sequestration portion of the housing 1630 to define and/or to form at least a portion of the sequestration chamber 1634 .
  • the diaphragm 1676 can be configured to transition, move, flip, and/or otherwise reconfigure from a first state to a second state in response to a negative pressure differential, which can be operable to draw an initial volume of bodily fluid into the sequestration chamber 1634 and/or to sequester the initial volume of bodily fluid in the sequestration chamber 1634 once disposed therein.
  • the diaphragm 1676 can include and/or can be coupled to a flow controller 1642 .
  • the flow controller 1642 can be any suitable flow controller such as any of those described herein.
  • the flow controller 1642 can be a semi-permeable member or membrane such as an air permeable/liquid impermeable barrier (e.g., a blood barrier).
  • the flow controller 1642 can be configured to transition from a first state in which the flow controller 1642 allows a flow of gas (e.g., air) to pass through the flow controller 1642 while preventing a flow of liquid (e.g., bodily fluid) to pass therethrough, to a second state in which the flow controller 1642 limits and/or substantially prevents a flow of gas and liquid to pass through the flow controller 1642 .
  • the flow controller 1642 can be configured to transition from the first state to the second state in response to contact with, for example, the initial volume of bodily fluid (e.g., at least a portion of the initial volume of bodily fluid can wet or saturate the flow controller 1642 to place the flow controller 1642 in the second state).
  • the diaphragms 576 , 676 , and 776 are shown and described above as including a pin, rod, post, and/or the like that include and/or are coupled to one or more seals (e.g., the seals 565 , 665 , and 765 , respectively), in the embodiment shown in FIGS. 51 and 52 , the diaphragm 1676 includes a pin 1677 (e.g., a rod, an extension, a protrusion, a latch, a lock, and/or any other suitable feature, member, and/or mechanism) that does not include and/or is not coupled to a seal.
  • a pin 1677 e.g., a rod, an extension, a protrusion, a latch, a lock, and/or any other suitable feature, member, and/or mechanism
  • the pin 1677 extends through a portion of the housing 1630 to selectively engage a portion of the actuator rod 1662 , which in turn includes one or more seals (e.g., the seals 1665 and 1666 ), as described in further detail herein.
  • the actuator rod 1662 is movably disposed in, for example, an actuator portion 1639 of the housing 1630 .
  • the actuator rod 1662 includes a first seal 1665 and a second seal 1666 and is in contact with an energy storage member 1667 such as a spring or the like disposed within the actuator portion 1639 of the housing 1630 .
  • the arrangement of the actuator 1650 can be such that a first end portion of the actuator rod 1662 is in selective contact with the pin 1677 of the diaphragm 1676 and a second end portion of the actuator rod 1662 (opposite the first end portion) is in contact with and/or otherwise is engaged with the energy storage member 1667 .
  • the pin 1677 of the diaphragm 1676 can engage the actuator rod 1662 to maintain the actuator rod 1662 in a first or initial state and/or position in which the energy storage member 1667 has a relatively high potential energy (e.g., the energy storage member 1667 can be a spring maintained and/or held in a compressed state when in the first state).
  • the first seal 1665 coupled to and/or disposed on the actuator 1662 is in a first or initial position in which the fluid flow path 1633 establishes fluid communication between the inlet 1631 and the sequestration chamber 1634 when the actuator 1650 is in the first state.
  • the second seal 1666 coupled to and/or disposed on the actuator rod 1662 is likewise in a first or initial position in which the second seal 1666 is spaced apart from a seal surface 1640 formed by at least a portion of the actuator portion 1639 of the housing 1630 .
  • the separation of the second seal 1666 from the seal surface 1640 can be such that the fluid flow path 1654 places the outlet 1636 in fluid communication with the sequestration chamber 1634 via a restricted flow path 1632 (see FIG. 52 ).
  • the restricted flow path 1632 can be similar in at least form and/or function to any of the restricted flow paths described herein (e.g., the restricted flow paths 232 , 832 , 1232 , and/or 1332 ).
  • the restricted flow path 1632 can be configured to modulate a magnitude of a negative pressure differential applied on or in the sequestration chamber 1634 and/or a rate at which a negative pressure differential increases within the sequestration chamber 1634 .
  • the outlet 1636 can be in fluid communication with the sequestration chamber 1634 via any suitable flow path, port, opening, valve, etc.
  • the control device 1600 need not include the restricted flow path 1632 .
  • the actuator rod 1662 can be maintained in a first state or position in which the fluid flow path 1633 places the inlet 1631 in fluid communication with the sequestration chamber 1634 , and the fluid flow path 1654 places the outlet 1636 in fluid communication with the sequestration chamber 1634 via the restricted flow path 1632 .
  • a fluid collection device such as those described herein
  • a negative pressure defined in and/or otherwise produced by the fluid collection device can be operable to draw the initial volume of bodily fluid into the sequestration chamber 1634 .
  • the actuator 1650 can be transitioned to a second state and/or configuration in response to the initial volume being transferred into the sequestration chamber 1634 .
  • the initial volume of bodily fluid can be drawn into the sequestration chamber 1634 in response to a negative pressure being exerted through the flow controller 1642 (e.g., the selectively permeable membrane).
  • the flow controller 1642 e.g., the selectively permeable membrane
  • at least a portion of the bodily fluid drawn into the sequestration chamber 1634 can come into contact with the flow controller 1642 , which in turn, can transition the flow controller 1642 from the first state to the second state (e.g., the flow controller 1642 limits and/or substantially prevents a flow of gas and liquid therethrough).
  • a negative pressure exerted on a surface of the diaphragm 1676 can build and can become sufficient to transition, move, and/or flip the diaphragm from a first state and/or configuration to a second state and/or configuration (see FIG. 52 ).
  • the transitioning of the diaphragm 1676 can correspond with and/or can be in response to the flow controller 1642 being transitioned from the first state to the second state (e.g., becoming fully wetted or the like, as described in detail above).
  • the diaphragm 1676 can transition before or after the flow controller 1642 has transitioned from the first state to the second state.
  • control device 1600 need not include the flow controller 1642 and the diaphragm 1676 can be configured to transition in response to being exposed to the negative pressure differential produced by the fluid collection device.
  • the diaphragm 1676 (and/or at least a portion thereof) can be configured to act in a similar manner to the flow controller 1642 by transitioning from the first state to the second state in a predictable and/or predetermined manner after being exposed to a predetermined negative pressure differential or a predetermined rate of change in negative pressure.
  • the transitioning of the diaphragm 1676 can be automatic (e.g., is not a result of user intervention).
  • the pin 1677 can be moved within the housing 1630 and relative to the actuator rod 1662 . More particularly, the transitioning of the diaphragm 1676 can move the pin 1677 a sufficient amount that the pin 1677 is disengaged from the actuator rod 1662 .
  • the energy storage member 1667 e.g., spring
  • moving the pin 1677 can allow the spring 1667 to expand from a first or compressed state to a second or substantially uncompressed state.
  • the transitioning of the energy storage member 1667 (e.g., spring) from the first state to the second state moves the actuator rod 1662 within the actuator portion 1639 from a first state and/or position to a second state and/or position.
  • the first seal 1665 can be placed in a second or subsequent position in which the first seal 1665 sequesters the sequestration chamber 1634 from the inlet 1631 .
  • the second seal 1666 can be placed in a second or subsequent position in which the second seal 1666 is pushed (e.g., by the energy storage member 1667 ) against the seal surface 1640 , which in turn, sequesters the flow controller 1642 from the fluid flow path 1654 .
  • the placement of the first seal 1665 and the second seal 1666 when the actuator rod 1662 is in the second state and/or position is such that the fluid flow path 1633 is placed in fluid communication with the fluid flow path 1654 .
  • a negative pressure differential produced by the fluid collection device coupled to the outlet 1636 can be operable to draw a subsequent volume of bodily fluid from the inlet 1631 , through the fluid flow path 1633 and 1654 , through the outlet 1636 , and into the fluid collection device.
  • the collecting and sequestering of the initial volume of bodily fluid can result in the subsequent volume(s) of bodily fluid being substantially free from contaminants, as described in detail above.
  • the fluid control device can be similar to and/or substantially the same as any of the fluid control devices described in detail above.
  • the method 10 includes establishing fluid communication between a bodily fluid source and an inlet of the fluid collection device, at 11 .
  • a user can manipulate the fluid control device to physically and/or fluidically couple the inlet to a lumen-containing device (e.g., a needle, IV, PICC line, etc.) in fluid communication with a patient.
  • a lumen-containing device e.g., a needle, IV, PICC line, etc.
  • a fluid collection device is coupled to an outlet of the fluid control device, at 12 .
  • the coupling of the fluid collection device to the outlet is configured to produce a negative pressure differential within at least a portion of the fluid control device, as described in detail above.
  • the fluid collection device can be a sample bottle or container that defines a negative pressure.
  • the fluid collection device can be a syringe or the like that can be manipulated to produce a negative pressure.
  • a negative pressure differential can be produced within one or more portions of the fluid control device, as described above with reference to the control devices 100 , 200 , 300 , 400 , 500 , 600 , 700 , 800 , 900 , 1000 , 1100 , 1200 , 1300 , 1400 , 1500 , and/or 1600 .
  • an initial volume of bodily fluid is received from the inlet and into a sequestration portion of the fluid control device in response to the negative pressure differential, at 13 .
  • the sequestration portion can be similar to and/or substantially the same as the sequestration chamber 1234 described above with reference to FIGS. 29-34 .
  • the sequestration portion can be similar to and/or substantially the same as the sequestration chamber 1634 .
  • the sequestration portion can be similar to and/or substantially the same as any of the sequestration chambers described herein.
  • the initial volume of bodily fluid can include contaminants entrained therein, which may otherwise result in false results during testing of a bodily fluid sample.
  • a flow controller disposed in the sequestration portion is transitioned from a first state in which the flow controller allows a flow of a gas through the flow controller and prevents a flow of bodily fluid through the flow controller, to a second state in which the flow controller prevents a flow of gas and bodily fluid through the flow controller, at 14 .
  • the flow controller can be a selectively permeable member or membrane (e.g., a fluid or blood barrier and/or the like), as described above with reference to the flow controller 242 .
  • the flow controller can be similar to and/or substantially the same as any of the flow controllers described herein.
  • the contact with at least the portion of the initial volume of bodily fluid can, for example, wet or saturate the flow controller such that the flow controller limits and/or substantially prevents a flow of gas and liquid (e.g., bodily fluid) therethrough.
  • the flow controller can be a bladder and/or diaphragm that is configured to be transitioned in response to a negative pressure differential.
  • a flow controller can be a substantially impermeable bladder or diaphragm that can transition from a first state to a second state when a negative pressure differential applied to a surface of the bladder and/or diaphragm exceeds a threshold amount of negative pressure.
  • the fluid control device can include an actuator and/or any other suitable feature or mechanism configured to transition after the flow controller is placed in its second configuration to sequester the initial volume of bodily fluid.
  • the actuator can transition from a first state to a second state to automatically sequester the initial volume of bodily fluid in the sequestration portion, as described above with reference to, for example, the actuator 1650 .
  • the actuator can transition from a first state to a second state in response to a force exerted by a user, as described above with reference to, for example, the actuator 850 .
  • the fluid control device can sequester the initial volume of bodily fluid in the sequestration portion in any suitable manner such as those described herein.
  • a subsequent volume of bodily fluid is transferred from the inlet, through the outlet, and into the fluid collection device, at 16 .
  • sequestering the initial volume of bodily fluid in the sequestration portion of the fluid control device can likewise sequester contaminants contained in the initial volume. Accordingly, contaminants in the subsequent volume of bodily fluid can be reduced or substantially eliminated.
  • control devices 100 , 200 , 300 , 400 , 500 , 600 , 700 , 800 , 900 , 1000 , 1100 , 1200 , 1300 , 1400 , and/or 1500 are described as transferring a bodily fluid into the device as a result of a negative pressure within a fluid collection device, in other embodiments, the devices described herein can be used with any suitable device configured to establish a pressure differential (e.g., a negative pressure differential).
  • a pressure differential e.g., a negative pressure differential
  • an outlet of a control device can be coupled to a syringe or pump.
  • a control device can include a pre-charged sequestration chamber, a vented sequestration chamber, a manually activated device configured to produce a negative pressure, an energy source (e.g., a chemical energy source, a kinetic energy source, and/or the like), and/or any other suitable means of defining and/or forming a pressure differential within a portion of the control device.
  • an energy source e.g., a chemical energy source, a kinetic energy source, and/or the like
  • the control devices can be coupled to such collection devices by a user (e.g., doctor, nurse, technician, physician, etc.) or can be coupled or assembled during manufacturing.
  • pre-assembling a control device and a collection device can, for example, force compliance with a sample procurement protocol that calls for the sequestration of an initial amount of bodily fluid prior to collecting a sample volume of bodily fluid.
  • a fluid control device can include any suitable flow controller and/or actuator configured to selectively control a flow of bodily fluid through one or more portions of the fluid control device.
  • a fluid control device can include one or more seals having any suitable configuration.
  • a fluid control device can include one or more seals arranged as an elastomeric sheet or the like that is/are fixedly coupled to a portion of the control device.
  • a portion of an actuator such as a pin or rod extending from a diaphragm (see e.g., FIGS. 11 and 12 ) can extend through an opening defined in the one or more elastomeric sheets, which in turn, form a substantially fluid tight seal with an outer surface of the pin or rod.
  • the portion of the actuator e.g., the pin or rod
  • the portion of the actuator moves relative to the one or more elastomeric sheets, which in turn, remain in a substantially fixed position relative to the portion of the control device.
  • the removal or the portion of the actuator can allow a flow of fluid through the opening defined by the one or more elastomeric sheets that was otherwise occluded by the portion of the actuator.
  • the one or more elastomeric sheets can function in a similar manner as any of the seals described herein.
  • such an arrangement may, for example, reduce an amount of friction associated with forming the desired fluid tight seals, which in turn, may obviate the use of a lubricant otherwise used to facilitate the movement of the seals within the control device.
  • a fluid control device can include any suitable actuator or the like configured to transition, move, flip, and/or otherwise reconfigure in response to being exposed to a desired and/or predetermined amount of negative pressure.
  • a fluid control device can include an actuator including and/or arranged as a movable member, plug, plunger, occlusion member, seal, and/or the like configured to selectively control a flow of fluid through at least a portion of the fluid control device. More particularly, the movable member or the like can be transitioned from a first state and/or position in which the movable member or the like is disposed in and/or otherwise occludes an opening, to a second state and/or position in which the movable member or the like is removed from the opening. In such embodiments, a negative pressure can be exerted through a portion of the device to transfer, for example, an initial volume of bodily fluid into a sequestration portion and/or chamber.
  • a device can include a flow controller such as a selectively permeable member or membrane, that can be configured to transition from a first state to a second state in response to being wetted (or otherwise transitioned) by the initial volume of bodily fluid.
  • a flow controller such as a selectively permeable member or membrane
  • an amount of negative pressure exerted on a surface of the movable member or the like may build until a magnitude of the negative pressure is sufficient to pull or move the movable member out of the opening, thereby allowing a flow of bodily fluid through the opening that was otherwise occluded by the movable member.
  • the movable member can function similar to any of the diaphragms described herein (e.g., the diaphragm 576 , 676 , and/or 776 ) that are configured to transition or flip from a first state to a second state.
  • the movable member can be, for example, an elastomeric plug, cork, plunger, and/or any other suitable member that can be moved or “popped” out of such an opening or portion of a flow path.
  • a control device can be arranged to transfer a flow of bodily fluid in response to negative pressure differentials resulting from any suitable portion(s) of the device.
  • a control device can include a sequestration chamber that is a pre-sealed evacuated and/or charged chamber such that establishing fluid communication between an inlet and the sequestration chamber results in a negative pressure differential that is sufficient to draw an initial volume of bodily fluid into the sequestration chamber.
  • control device can be configured to transfer bodily fluid to the sequestration chamber until the pressure differential is sufficiently reduced and/or until pressures otherwise substantially equalize.
  • the sequestration chamber and/or the inlet can include a coupler, an actuator, a needle, a septum, a port, and/or any other suitable member that can establish fluid communication therebetween (e.g., that can transition the sequestration chamber from a sealed to an unsealed configuration).
  • an actuator such as the actuator 1250 can be transitioned from a first state in which an initial volume of bodily fluid can flow from an inlet to a sequestration chamber or portion, to a second state in which (1) the sequestration chamber or portion is physically and/or mechanically sequestered and (2) the inlet is in fluid communication with an outlet of the fluid control device.
  • an actuator and/or any other suitable portion of a fluid control device can transition from a first state in which an initial volume of bodily fluid can flow from an inlet to a sequestration chamber or portion, to a second state in which the inlet is placed in fluid communication with the outlet without physically and/or mechanically sequestering (or isolating) the sequestration chamber or portion.
  • a control device is in the second state, one or more features and/or geometries of the control device can result in a preferential flow of bodily fluid from the inlet to the outlet and the initial volume of bodily fluid can be retained in the sequestration chamber or portion without physically and/or mechanically being sequestered or isolated.
  • a control device can include any suitable feature, mechanism, and/or device configured to modulate, create, and/or otherwise control one or more pressure differentials through at least a portion of the control device.
  • a user can transition and/or move an actuator to change (e.g., reduce or increase) the size of one or more portions of a fluid flow path or fluid flow interface within a portion of the control device to manually modulate and/or otherwise control an amount or magnitude of negative pressure within one or more portions of a control device.
  • the device 700 includes concepts, features, and/or elements of the devices 200 and 600 .
  • any of the embodiments described herein can include a lock or other suitable feature configured to at least temporarily maintain one or more components in a desired position, state, arrangement, and/or configuration.
  • any of the embodiments described herein can include and/or can define a sequestration chamber and/or portion that is configured similar to, for example, the sequestration chamber 1234 described above with reference to FIG. 30 .
  • any of the fluid control devices described herein can include a sequestration chamber that is arranged and/or formed as a channel.
  • a channel forming at least a portion of a sequestration chamber can have a relatively small cross-sectional shape and/or size that can reduce and/or substantially prevent mixing of air and bodily fluid as the initial volume of bodily fluid is drawn into the channel, as described above with reference to the sequestration chamber 1234 .
  • such a channel can have a spiral shape and/or configuration similar to the sequestration chamber 1234 described above and/or can have any other suitable shape and/or configuration.
  • any of the control devices described herein can include a flow controller arranged as a selectively permeable member or membrane as described above, for example, with reference to the flow controller 242 .
  • a portion of the diaphragm 676 can include and/or can form a flow controller formed, at least in part, of a selectively permeable material.
  • the flow controller can be configured to allow a volume of the sequestration chamber and/or portion 634 to be vented in response to being exposed to the negative pressure differential (as described above).
  • a volume of air can be drawn out of (e.g., vented from or purged from) the sequestration chamber 634 via the flow controller in response to the negative pressure differential within a portion of the fluid control device 600 .
  • such an arrangement can allow for a reduction in a size and/or volume of the sequestration chamber 634 because a volume of air otherwise occupying a portion of the sequestration chamber 634 is vented or purged through the flow controller in response to the negative pressure differential.
  • any of the embodiments described herein can include any suitable actuator and/or flow controller configured to selectively control fluid flow through at least a portion of the device.
  • a flow controller or the like can be one or more of a selectively permeable material or membrane, a valve, a diaphragm, and/or any other suitable flow controller.
  • any actuator described herein can include an actuator rod configured to transition from between a first position and second position to at least temporarily isolate an outlet of the device from one or more other portions of the device (e.g., as described above with reference to the actuators 850 and/or 1350 ).
  • an actuator can be configured for use with a given and/or predetermined collection device such as, for example, a syringe. In other embodiments, such an actuator can be used with any suitable collection device.
  • the specific configurations of the various components can also be varied.
  • the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein.
  • a portion of the actuator body 1551 , sequestration chamber 1534 , and/or the bladder 1578 are shown in FIGS. 45-50 as being substantially tubular having a round or substantially semi-circular end portion, in other embodiments, the portion of the actuator body 1551 , sequestration chamber 1534 , and/or bladder 1578 can have any suitable shape and/or size.
  • varying the size and/or shape of such components may reduce an overall size of the device 1500 and/or may increase the ergonomics of the device 1500 without changing the function of the device 1500 .
  • a housing, sequestration chamber, and/or bladder may have a substantially cylindrical shape with a relatively flat end portion or the like.
  • a control device can include a bladder that is configured to “flip” similar to the diaphragms described above in response to being exposed to a negative pressure differential.
  • a bladder can be configured to gradually transition (e.g., unroll, unfold, unfurl, and/or otherwise reconfigure) from the first state to the second state. In some instances, controlling a rate at which a bladder is transitioned may allow for a modulation and/or control of a negative pressure differential produced within the sequestration chamber.
  • a device may include a bladder (similar in form and/or function to the bladders 1478 and/or 1578 ) disposed in a housing having a size, shape, and/or profile similar to the housings 1230 and/or 1330 .
  • the bladder can define a volume that is similar in shape and/or size the overall size, and/or shape of the housing (e.g., cylindrical with a relatively low profile or height).
  • such an arrangement can allow at least a portion of an initial volume of bodily fluid to remain in contact with a surface of the bladder (or diaphragm or other actuator), which can provide a visual indication to the user regarding the bodily fluid being transferred into the sequestration chamber.
  • a housing similar to the housing 1230 can define a spiral channel or any other suitable channel and can include a bladder disposed within at least a portion of that channel.
  • the bladder can function similarly to the bladder 1578 in which the bladder expands, opens, and/or otherwise increases in volume in response to being exposed to a negative pressure differential.
  • a bladder can define an enclosed volume configured to receive an initial volume of bodily fluid.
  • the bladder and a portion of the housing e.g., a surface defining the sequestration chamber and/or channel
  • a fluid control device can include a bladder configured to conform to any suitable shape, feature, channel, and/or configuration of a housing in which it is disposed.
  • the size and shape of the various components can be specifically selected for a desired rate and/or volume of bodily fluid flow into a fluid reservoir.
  • the size and/or shape of the various components can be specifically selected for a desired or intended usage.
  • a device such as those described herein can be configured for use with or on seemingly healthy adult patients.
  • the device can include a sequestration chamber that has a first volume (e.g., about 0.5 ml to about 5.0 ml).
  • a device such as those described herein can be configured for use with or on, for example, very sick patients and/or pediatric patients.
  • the device can include a sequestration chamber that has a second volume that is less than the first volume (e.g., less than about 0.5 ml).
  • any of the devices described herein can include an opening, port, coupler, septum, Luer-Lok, gasket, valve, threaded connecter, standard fluidic interface, etc. (referred to for simplicity as a “port”) in fluid communication with the sequestration chamber.
  • the port can be configured to couple to any suitable device, reservoir, pressure source, etc.
  • the port can be configured to couple to a reservoir, which in turn, can allow a greater volume of bodily fluid to be diverted and/or transferred into the sequestration chamber.
  • the port can be coupled to a negative pressure source such as an evacuated container, a pump, a syringe, and/or the like to collect a portion of or the full volume of bodily fluid in the sequestration chamber, channel, reservoir, etc. and use that volume of bodily fluid (e.g., the pre-sample volume) for additional clinical and/or in vitro diagnostic testing purposes.
  • a negative pressure source such as an evacuated container, a pump, a syringe, and/or the like to collect a portion of or the full volume of bodily fluid in the sequestration chamber, channel, reservoir, etc. and use that volume of bodily fluid (e.g., the pre-sample volume) for additional clinical and/or in vitro diagnostic testing purposes.
  • the port can be configured to receive a probe, sampling tool, testing device, and/or the like that can be used to perform one or more tests (e.g., tests not sensitive to potential contamination) on the initial volume while the initial volume is disposed or sequestered in the
  • the port can be coupled to any suitable pressure source or infusion device configured to infuse the initial volume of bodily fluid sequestered in the sequestration chamber back into the patient and/or bodily fluid source (e.g., in the case of pediatric patients, very sick patients, patients having a low blood volume, and/or the like).
  • the sequestration channel, chamber, and/or reservoir can be configured with the addition of other diagnostic testing components integrated into the chamber (e.g., a paper test) such that the initial bodily fluid is used for that test.
  • the sequestration chamber, channel, and/or reservoir can be designed, sized, and configured to be removable and compatible with testing equipment and/or specifically accessible for other types of bodily fluid tests commonly performed on patients with suspected conditions.
  • a patient with suspected sepsis commonly has blood samples collected for lactate testing, procalcitonin testing, and blood culture testing.
  • All of the fluid control devices described herein can be configured such that the sequestration chamber, channel, reservoir, etc. can be removed (e.g., after receiving the initial volume of bodily fluid) and the bodily fluid contained therein can be used for these additional testing purposes before or after the subsequent sample is collected for microbial testing.
  • a fluid control device can include one or more lumen, channels, flow paths, etc. configured to selectively allow for a “bypass” flow of bodily fluid, where an initial amount or volume of bodily fluid can flow from the inlet, through the lumen, cannel, flow path, etc. to bypass the sequestration chamber, and into the collection device.
  • the fluid control device can include an actuator having, for example, at least three states—a first in which bodily fluid can flow from the inlet to the sequestration chamber, a second in which bodily fluid can flow from the inlet to the outlet after the initial volume is sequestered in the sequestration chamber, and a third in which bodily fluid can flow from the inlet, through the bypass flow path, and to the outlet.
  • the control device can include a first actuator configured to transition the device between a first and second state, as described in detail above with reference to specific embodiments, and can include a second actuator configured to transition the device to a bypass configuration or the like.
  • the control device can include any suitable device, feature, component, mechanism, actuator, controller, etc. configured to selectively place the fluid control device in a bypass configuration or state.
  • any of the embodiments described herein can be used in conjunction with any suitable fluid transfer, fluid collection, and/or fluid storage device such as, for example, the fluid reservoirs described in the '420 patent.
  • any of the embodiments described herein can be used in conjunction with any suitable transfer adapter, fluid transfer device, fluid collection device, and/or fluid storage devices such as, for example, the devices described in the '510 Publication and/or any of the devices described in U.S. Patent Publication No. 2015/0246352 entitled, “Apparatus and Methods for Disinfection of a Specimen Container,” filed Mar. 3, 2015; U.S. Pat. No. 8,535,241 entitled, “Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filed Oct.
  • a method of using a fluid control device can include the ordered steps of establishing fluid communication between a bodily fluid source (e.g., a vein of a patient or the like) and an inlet of a fluid control device.
  • An outlet of the fluid control device is then placed in fluid communication with and/or otherwise engages a negative pressure source.
  • a negative pressure source can be a sample reservoir, a syringe, an evacuated container, an intermediate transfer device, and/or the like.
  • the fluid control device can be in a first state or operating mode when the outlet is coupled to the negative pressure source and, as such, a negative pressure differential is applied through the fluid control device that draws an initial volume of bodily fluid into a sequestration chamber of the fluid control device.
  • a negative pressure within a sample reservoir can be operable in drawing an initial volume of bodily fluid from a patient and into the sequestration chamber.
  • the fluid control device is transitioned, either automatically or via user intervention, from the first state or operating mode to a second state or operating mode such that (1) the initial volume is sequestered in the sequestration chamber and (2) the fluid communication is established between the inlet and the outlet.
  • the sequestration of the initial volume can be such that contaminants entrained in the flow of the initial volume are likewise sequestered within the sequestration chamber.
  • the transitioning from the first state to the second state may, in some instances, be relatively gradual such that as a last portion of the initial volume of bodily fluid is being transferred into the sequestration chamber, the housing begins to transition from the first state to the second state.
  • the rate of change when transitioning from the first state to the second state can be selectively controlled to achieve one or more desired characteristics associated with the transition.
  • the inflow of the last portion of the initial volume can limit and/or substantially prevent bodily fluid already disposed in the sequestration chamber from escaping therefrom. Accordingly, while the transitioning from the first state to the second state may occur over a given amount of time, the sequestration chamber can nonetheless sequester the volume of bodily fluid disposed therein.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Manufacturing & Machinery (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Analytical Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Feeding, Discharge, Calcimining, Fusing, And Gas-Generation Devices (AREA)
  • Iron Core Of Rotating Electric Machines (AREA)
US16/129,066 2017-09-12 2018-09-12 Fluid control devices and methods of using the same Active 2039-06-03 US11076787B2 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
US16/129,066 US11076787B2 (en) 2017-09-12 2018-09-12 Fluid control devices and methods of using the same
US17/390,249 US20220175284A1 (en) 2017-09-12 2021-07-30 Fluid control devices and methods of using the same
US17/883,340 US11653863B2 (en) 2017-09-12 2022-08-08 Fluid control devices and methods of using the same
US17/883,339 US11529081B2 (en) 2017-09-12 2022-08-08 Fluid control devices and methods of using the same
US18/130,207 US11903709B2 (en) 2017-09-12 2023-04-03 Fluid control devices and methods of using the same
US18/299,680 US11903710B2 (en) 2017-09-12 2023-04-12 Fluid control devices and methods of using the same
US18/407,010 US20240138734A1 (en) 2017-09-12 2024-01-08 Fluid control devices and methods of using the same
US18/680,348 US20240315621A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,466 US20240315624A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,377 US20240315622A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,331 US20240315620A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,439 US20240315623A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201762557530P 2017-09-12 2017-09-12
US201862634569P 2018-02-23 2018-02-23
US201862678632P 2018-05-31 2018-05-31
US16/129,066 US11076787B2 (en) 2017-09-12 2018-09-12 Fluid control devices and methods of using the same

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US17/390,249 Continuation US20220175284A1 (en) 2017-09-12 2021-07-30 Fluid control devices and methods of using the same

Publications (2)

Publication Number Publication Date
US20190076074A1 US20190076074A1 (en) 2019-03-14
US11076787B2 true US11076787B2 (en) 2021-08-03

Family

ID=65630000

Family Applications (12)

Application Number Title Priority Date Filing Date
US16/129,066 Active 2039-06-03 US11076787B2 (en) 2017-09-12 2018-09-12 Fluid control devices and methods of using the same
US17/390,249 Pending US20220175284A1 (en) 2017-09-12 2021-07-30 Fluid control devices and methods of using the same
US17/883,340 Active US11653863B2 (en) 2017-09-12 2022-08-08 Fluid control devices and methods of using the same
US17/883,339 Active US11529081B2 (en) 2017-09-12 2022-08-08 Fluid control devices and methods of using the same
US18/130,207 Active US11903709B2 (en) 2017-09-12 2023-04-03 Fluid control devices and methods of using the same
US18/299,680 Active US11903710B2 (en) 2017-09-12 2023-04-12 Fluid control devices and methods of using the same
US18/407,010 Pending US20240138734A1 (en) 2017-09-12 2024-01-08 Fluid control devices and methods of using the same
US18/680,466 Pending US20240315624A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,377 Pending US20240315622A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,439 Pending US20240315623A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,331 Pending US20240315620A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,348 Pending US20240315621A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same

Family Applications After (11)

Application Number Title Priority Date Filing Date
US17/390,249 Pending US20220175284A1 (en) 2017-09-12 2021-07-30 Fluid control devices and methods of using the same
US17/883,340 Active US11653863B2 (en) 2017-09-12 2022-08-08 Fluid control devices and methods of using the same
US17/883,339 Active US11529081B2 (en) 2017-09-12 2022-08-08 Fluid control devices and methods of using the same
US18/130,207 Active US11903709B2 (en) 2017-09-12 2023-04-03 Fluid control devices and methods of using the same
US18/299,680 Active US11903710B2 (en) 2017-09-12 2023-04-12 Fluid control devices and methods of using the same
US18/407,010 Pending US20240138734A1 (en) 2017-09-12 2024-01-08 Fluid control devices and methods of using the same
US18/680,466 Pending US20240315624A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,377 Pending US20240315622A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,439 Pending US20240315623A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,331 Pending US20240315620A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same
US18/680,348 Pending US20240315621A1 (en) 2017-09-12 2024-05-31 Fluid control devices and methods of using the same

Country Status (9)

Country Link
US (12) US11076787B2 (zh)
EP (2) EP4205640A1 (zh)
JP (1) JP7204742B2 (zh)
CN (2) CN111212597B (zh)
AU (2) AU2018334138B2 (zh)
CA (1) CA3074105A1 (zh)
ES (1) ES2939951T3 (zh)
IL (2) IL273025B1 (zh)
WO (1) WO2019055487A1 (zh)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210161448A1 (en) * 2018-06-07 2021-06-03 Becton, Dickinson And Company Biological fluid separation device
US20210267512A1 (en) * 2018-05-01 2021-09-02 Becton, Dickinson And Company Biological Fluid Micro-Sample Management Device
US11419531B2 (en) 2017-12-07 2022-08-23 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US11529081B2 (en) 2017-09-12 2022-12-20 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US11786155B2 (en) 2019-02-08 2023-10-17 Magnolia Medical Technologies, Inc. Devices and methods for bodily fluid collection and distribution
WO2023230520A1 (en) 2022-05-24 2023-11-30 Magnolia Medical Technologies, Inc. Fluid transfer devices with integrated flow-based assay and methods of using the same for identifying sepsis
US11857321B2 (en) 2019-03-11 2024-01-02 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US11890452B2 (en) 2012-10-11 2024-02-06 Magnolia Medical Technologies, Inc. Systems and methods for delivering a fluid to a patient with reduced contamination
US11998332B2 (en) 2012-05-30 2024-06-04 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US12083234B2 (en) 2015-09-03 2024-09-10 Magnolia Medical Technologies, Inc. Apparatus and methods for maintaining sterility of a specimen container
US12133968B2 (en) 2023-12-28 2024-11-05 Magnolia Medical Technologies, Inc. Systems and methods for delivering a fluid to a patient with reduced contamination

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3498168B1 (en) 2012-11-30 2021-01-20 Magnolia Medical Technologies, Inc. Syringe based fluid diversion mechanism for bodily-fluid sampling
US10772548B2 (en) 2012-12-04 2020-09-15 Magnolia Medical Technologies, Inc. Sterile bodily-fluid collection device and methods
JP6437515B2 (ja) 2013-03-12 2018-12-12 マグノリア メディカル テクノロジーズ，インコーポレイテッド 針の内腔を選択的に閉塞するための方法及び装置
US10010282B2 (en) 2015-07-24 2018-07-03 Kurin, Inc. Blood sample optimization system and blood contaminant sequestration device and method
IL267684B2 (en) 2016-12-27 2023-10-01 Kurin Inc A system for optimizing blood samples and a device and method for the determination of infection
US10827964B2 (en) 2017-02-10 2020-11-10 Kurin, Inc. Blood contaminant sequestration device with one-way air valve and air-permeable blood barrier with closure mechanism
US11986297B2 (en) * 2018-06-14 2024-05-21 Becton, Dickinson And Company Atmospheric-balanced vacuum for blood gas sample stabilization with an evacuated container
EP3948211A4 (en) * 2019-04-01 2022-11-30 Kurin, Inc. DEVICE AND SYSTEM FOR OPTIMIZING BODY FLUID SAMPLES WITHOUT VENTING
JP2022544145A (ja) * 2019-08-07 2022-10-17 ベクトン・ディキンソン・アンド・カンパニー 最初に採取した部分を隔離する採血装置
EP4073515A1 (en) 2019-12-11 2022-10-19 Magnolia Medical Technologies, Inc. Fluid transfer devices with integrated flow-based assay and methods of using the same
US20210275068A1 (en) 2020-03-06 2021-09-09 Magnolia Medical Technologies, Inc. Universal transfer adapters and methods of using the same
MX2022015161A (es) * 2020-06-01 2023-03-02 Kurin Inc Dispositivo y metodo de optimizacion de fluidos y contencion de contaminantes mediante tapon desplazable.
KR20230088386A (ko) * 2020-10-12 2023-06-19 벡톤 디킨슨 앤드 컴퍼니 용혈 방지 기능이 있는 채혈 주사기
WO2022201081A1 (en) 2021-03-25 2022-09-29 Inspire M.D Ltd. Device for shunting blood between the arterial and venous systems
CN113318284B (zh) * 2021-06-10 2022-10-11 青岛大学附属医院 一种儿科护理用的吸痰装置
MX2024000698A (es) * 2021-08-19 2024-02-07 Carefusion 303 Inc Accesorios de reduccion de hemolisis integrados en cateter intravenoso periferico sobre la aguja (pivc) con componente anti-derrame para extraccion directa de sangre.
US20230200692A1 (en) * 2021-12-23 2023-06-29 Carefusion 303, Inc. Hemolysis-reduction accessories for direct blood draw
US20230363675A1 (en) * 2022-05-12 2023-11-16 Carefusion 303, Inc. Hemolysis-reduction accessories for direct blood draw
CN114878440B (zh) * 2022-07-08 2022-10-28 深圳市帝迈生物技术有限公司 一种样本分析仪及其堵孔检测方法
US12116562B1 (en) * 2023-12-16 2024-10-15 Unicorn Biotechnologies Ltd. Integrated system for the automated passaging of anchorage dependent cell cultures

Citations (304)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2707953A (en) 1952-07-15 1955-05-10 Abbott Lab Transfusion equipment
US2992974A (en) 1960-04-04 1961-07-18 Allan S Belcove Biological testing device
US3013557A (en) 1959-04-13 1961-12-19 Hazleton Lab Inc Combination syringe, shipping container and centrifuge tube
US3098016A (en) 1961-07-26 1963-07-16 American Cyanamid Co Process for producing sterile vials containing culture media and a carbon dioxide atmosphere
US3382865A (en) 1965-10-18 1968-05-14 Ashton L. Worrall Jr. Device for taking multiple blood samples or the like
US3405706A (en) 1965-04-22 1968-10-15 Cinqualbre Paul Arrangement for taking blood
US3467095A (en) 1967-04-24 1969-09-16 Eugene Ross Lab Inc Blood collection set
US3467021A (en) * 1968-02-12 1969-09-16 Mec O Matic Inc Fluid pressure operated pump
US3494351A (en) 1966-06-21 1970-02-10 Ferrell S Horn Multiple vial fluid collecting device
US3494352A (en) 1969-03-26 1970-02-10 Becton Dickinson Co Apparatus for taking multiple samples
US3577980A (en) 1968-05-28 1971-05-11 Milton J Cohen Fluid extraction device
US3604410A (en) 1968-09-11 1971-09-14 Gary L Whitacre Multitube blood sampler
US3635798A (en) 1969-03-24 1972-01-18 William R Kirkham Blood and fluid culturing system
US3648684A (en) 1970-08-04 1972-03-14 Cleora W Barnwell Device for the direct transfer of blood from a human to culture bottles
DE7203008U (de) 1971-11-05 1972-05-10 Immuno Ag Fuer Chem-Med Prod Kombiniertes blutabnahme- und infusionsgeraet
US3680558A (en) 1970-05-27 1972-08-01 Robert F Kapelowitz Syringe with multiple compartments
US3730168A (en) 1970-09-10 1973-05-01 Kendall & Co Manometer
US3741197A (en) 1970-09-04 1973-06-26 Micromedia Syst Inc Percussion apparatus for blood sampling
JPS4846180A (zh) 1971-10-08 1973-07-02
US3777773A (en) 1972-02-22 1973-12-11 Koehring Co Pressure compensating valve mechanism
US3803810A (en) 1972-05-01 1974-04-16 Pall Corp Liquid-gas separator and filter
US3817240A (en) 1972-06-28 1974-06-18 Becton Dickinson Co Multiple sample needle assembly with one-way valve and blood flow indicator
US3834372A (en) 1973-01-12 1974-09-10 S Turney Disposable manifold with atmospheric vent
US3835835A (en) 1972-11-07 1974-09-17 Richardson Merrell Inc Two compartment locking sampling syringe
US3848579A (en) 1973-02-23 1974-11-19 Real A Villa Automatic elasto-valvular hypodermic sampling needle
US3874367A (en) 1972-06-29 1975-04-01 Becton Dickinson Co Valved blood sampling needle assembly
US3886930A (en) 1971-04-30 1975-06-03 Abbott Lab Blood collecting assembly
US3890203A (en) 1972-01-06 1975-06-17 Becton Dickinson Co Method and apparatus for the collection, cultivation and identification of microorganisms from body fluid
US3890968A (en) 1971-06-25 1975-06-24 Sci Systems Inc Fluid flow control means
US3937211A (en) 1972-10-27 1976-02-10 Fa. Walter Sarstedt Kunststoff-Spritzgusswerk Multi-purpose syringe
US3945380A (en) 1974-08-21 1976-03-23 Cutter Laboratories, Inc. Plasmapheresis assembly
US3978846A (en) 1975-01-02 1976-09-07 Bailey Donald L Syringe for taking blood samples
DE2541494A1 (de) 1975-08-18 1977-03-31 Guerra Luis A Blutentnahmevorrichtung
US4056101A (en) 1976-09-01 1977-11-01 Baxter Travenol Laboratories, Inc. Means for reducing tissue thromboplastin in collected blood
US4057050A (en) 1974-11-29 1977-11-08 Sarstedt W Devices for extracting blood
US4063460A (en) 1975-08-28 1977-12-20 Jan Axel Svensson Method for evacuating and then collecting medium samples in containers sealed by a resilient stopper at substantially atmospheric pressure
US4077395A (en) 1975-10-15 1978-03-07 St. Thomas's Hospital Medical School Apparatus for taking blood samples from a living patient
US4106497A (en) 1977-02-04 1978-08-15 Becton, Dickinson And Company Multiple sample needle assembly with indicator means
US4133863A (en) 1977-03-23 1979-01-09 Sherwood Medical Industries, Inc. Collection tube assembly and method for collecting biological fluids
US4133304A (en) * 1977-04-29 1979-01-09 Emde Corporation Syringe-like apparatus with removable capillary cartridge
US4150089A (en) 1977-09-06 1979-04-17 Linet Michael S Multi-chamber test tube
US4154229A (en) 1977-08-10 1979-05-15 Becton, Dickinson And Company Blood collection system with venipuncture indicator
US4166450A (en) 1977-07-22 1979-09-04 Metatech Corporation Device and procedure for collecting a succession of intravenous blood samples
US4190426A (en) 1977-11-30 1980-02-26 Baxter Travenol Laboratories, Inc. Gas separating and venting filter
US4193400A (en) 1978-06-16 1980-03-18 The Deseret Company Intravenous needle assembly with air bleed plug
US4207870A (en) * 1978-06-15 1980-06-17 Becton, Dickinson And Company Blood sampling assembly having porous vent means vein entry indicator
US4212308A (en) 1977-12-27 1980-07-15 Becton, Dickinson And Company Parallel-flow one-way blood sampling device
US4238207A (en) 1979-01-11 1980-12-09 Baxter Travenol Laboratories, Inc. Method of mounting a filter membrane
US4257416A (en) 1979-05-03 1981-03-24 David Prager Multi-channel venipuncture infusion set
US4275730A (en) 1979-11-05 1981-06-30 Becton, Dickinson And Company Syringe with pressure-limited delivery
US4298358A (en) 1979-01-11 1981-11-03 Baxter Travenol Laboratories, Inc. Gas separating and venting filter
US4340067A (en) 1980-03-31 1982-07-20 Rattenborg Christen C Blood collection syringe
US4340068A (en) 1980-06-18 1982-07-20 Becton, Dickinson And Company Multiple sample needle with vein entry indicator
US4349035A (en) 1978-03-14 1982-09-14 Johnson & Johnson Blood collection assembly with unidirectional flow valve
US4370987A (en) 1980-10-07 1983-02-01 Seymour Bazell Medical fluid collection device
US4398544A (en) 1981-10-15 1983-08-16 Becton Dickinson And Company Single and multiple sample needle assembly with vein entry indicator
US4412548A (en) 1981-07-30 1983-11-01 Becton Dickinson And Company Multiple sample needle assembly
US4416290A (en) 1982-08-30 1983-11-22 Becton Dickinson And Company Multiple sample needle assembly with vein indication
US4425235A (en) 1982-03-22 1984-01-10 Sherwood Medical Company Blood collection device with phase partitioning means
US4444203A (en) 1982-03-26 1984-04-24 Lab-A-Cath, Inc. Intravenous catheter placing and specimen gathering device
US4459997A (en) 1981-11-03 1984-07-17 Walter Sarstedt Kunststoff-Spritzgusswerk Blood extracting and centrifuging device
US4509534A (en) 1982-06-14 1985-04-09 Tassin Jr Myron J Blood withdrawal apparatus and method of using same
US4608996A (en) 1984-08-10 1986-09-02 Cordis Corporation External blood parameter diagnostic system
WO1986005568A1 (en) 1985-03-15 1986-09-25 Jan Axel Svensson Slide valve and coupler assembly
US4654027A (en) 1985-10-30 1987-03-31 Dragan William B Vascular dilating device
US4657160A (en) 1984-09-13 1987-04-14 Andy Woods Pressure infusion control
US4657027A (en) 1984-02-04 1987-04-14 Ferring Biotechnik Gmbh Means for taking blood samples for the diagnosis of bodily functions
US4673386A (en) 1986-03-06 1987-06-16 Gordon Mark G Blood sampler device
US4676256A (en) 1986-03-24 1987-06-30 Golden Theodore A Hypodermic device
US4679571A (en) 1984-08-31 1987-07-14 Becton, Dickinson And Company Blood sample needle assembly with vein indicator
US4705497A (en) 1985-05-31 1987-11-10 Terumo Kabushiki Kaisha Blood reservoir
US4714461A (en) 1985-11-07 1987-12-22 Becton, Dickinson And Company Catheter assembly with air purging feature
US4772273A (en) 1985-12-13 1988-09-20 Becton, Dickinson And Company Variable-volume vented container
US4865583A (en) 1987-05-04 1989-09-12 Tu Ho C Combination blood sampling and intravenous infusion apparatus and method
US4879098A (en) 1985-01-25 1989-11-07 Becton, Dickinson And Company Device for the separation of the lighter fraction from the heavier fraction of a liquid sample
US4886072A (en) 1983-12-16 1989-12-12 Becton, Dickinson And Company Multiple sample needle assembly with vein indicator
US4890627A (en) 1987-11-09 1990-01-02 Habley Medical Technology Corporation Manually evacuated suction tube
US4904240A (en) 1988-06-09 1990-02-27 Hoover Rocklin L Method and apparatus for starting intravenous solutions
WO1990004351A1 (en) 1988-10-20 1990-05-03 Lineback Paul I Methods and apparatus for obtaining arterial blood samples
US4980297A (en) 1987-02-27 1990-12-25 Becton, Dickinson And Company Device for the membrane separation of the components of a liquid sample
US4988339A (en) 1988-12-30 1991-01-29 Vadher Dinesh L Retractable needle/syringe devices for blood collection, catheterization, and medicinal injection procedures
US5006114A (en) 1990-04-20 1991-04-09 Rogers Bobby E Medical valve assembly
US5009847A (en) 1984-06-22 1991-04-23 Solomons Clive C Kit for determining blood platelet stress
US5027827A (en) 1990-03-28 1991-07-02 Cody Michael P Vacuum biopsy apparatus
US5032116A (en) 1991-01-09 1991-07-16 Becton, Dickinson And Company Flashback plug
US5045185A (en) 1986-11-10 1991-09-03 Terumo Kabushiki Kaisha Blood separator for separating blood components from a blood bag into separation bags
EP0448795A2 (en) 1990-03-29 1991-10-02 Becton, Dickinson and Company Compartmental body fluid collection tube
US5066284A (en) 1989-05-11 1991-11-19 Becton, Dickinson And Company Vent for flashback plug
WO1991018632A1 (en) 1990-05-25 1991-12-12 St. Jude Medical, Inc. Fluid control valve
US5084034A (en) 1990-06-08 1992-01-28 Tufts University Method for sampling body fluids
US5097842A (en) 1990-07-23 1992-03-24 Bonn Gina B Device for withdrawing fluids
US5100394A (en) 1988-01-25 1992-03-31 Baxter International Inc. Pre-slit injection site
US5108927A (en) 1985-09-04 1992-04-28 Wadley Technologies, Inc. Specimen transport device containing a specimen stabilizing composition
US5116323A (en) 1991-01-22 1992-05-26 Becton, Dickinson And Company Arterial catheter
US5122129A (en) 1990-05-09 1992-06-16 Olson Donald J Sampler coupler device useful in the medical arts
US5135489A (en) 1988-01-25 1992-08-04 Baxter International Inc. Pre-slit injection site and tapered cannula
WO1992016144A1 (en) 1991-03-15 1992-10-01 Goldspill Pty. Ltd. Body fluid extraction device
US5222502A (en) 1990-09-26 1993-06-29 Terumo Kabushiki Kaisha Blood collecting needle
US5269317A (en) 1989-06-08 1993-12-14 Bennett Scientific, Inc. Intravenous blood sampling apparatus
US5330464A (en) 1992-03-11 1994-07-19 Baxter International Inc. Reliable breakable closure mechanism
US5360011A (en) 1993-07-13 1994-11-01 Mccallister Teresa D Blood sample collection
JPH0716219A (ja) 1993-06-30 1995-01-20 Yoshikiyo Amagi 血管留置カテーテルからの採血方法及びそれに使用する器具
US5417673A (en) 1993-01-13 1995-05-23 Medex, Inc. Whole blood sample needleless sample site
US5429610A (en) 1993-11-19 1995-07-04 Vaillancourt; Vincent L. Dual chamber syringe for collecting samples and blood collecting system
US5431811A (en) 1992-05-19 1995-07-11 Hospal Ag Artificial kidney with device for filtering dialysis liquid
US5439450A (en) 1994-07-18 1995-08-08 Becton, Dickinson And Company Method of delivering a blood sample to an evacuated receptacle
US5450856A (en) 1994-04-25 1995-09-19 Norris; Wendal A. Phlebotomy needle attachable to a vacuum container with a vent to preclude blood flashback
US5466228A (en) 1991-01-25 1995-11-14 California State University, Fresno Foundation Fluid control apparatus
US5472605A (en) 1994-03-10 1995-12-05 Hemasure, Inc. Filtration device useable for removal of leukocytes and other blood components
US5485854A (en) 1994-04-12 1996-01-23 Smiths Industries Medical Systems, Inc. Safety blood collection tube holder and assembly therefor
US5507299A (en) 1994-06-13 1996-04-16 Roland; Patricia D. Multi-vial blood collection system
US5520193A (en) 1993-02-22 1996-05-28 Issei Suzuki Blood collecting needle with vein indicator
US5573510A (en) 1994-02-28 1996-11-12 Isaacson; Dennis R. Safety intravenous catheter assembly with automatically retractable needle
US5575777A (en) 1993-11-15 1996-11-19 Becton Dickinson And Company Retractable needle cannula insertion set with refinements to better control leakage, retraction speed and reuse
US5603700A (en) 1993-12-27 1997-02-18 Daneshvar; Yousef Suction and injection system
US5632906A (en) 1992-06-30 1997-05-27 Terumo Kabushiki Kaisha Apparatus and method for transferring separated component in liquid from a flexible bag in a centrifugal container
WO1997018845A1 (es) 1995-11-23 1997-05-29 Santiago Coca Perez Jeringa automatica, presurizada y precargada
US5649912A (en) 1994-03-07 1997-07-22 Bioject, Inc. Ampule filling device
US5691486A (en) 1996-07-30 1997-11-25 Bayer Corporation Apparatus and methods for selecting a variable number of test sample aliquots to mix with respective reagents
US5749857A (en) 1996-04-25 1998-05-12 Cuppy; Michael J. Catheter system
US5762633A (en) 1993-10-26 1998-06-09 Eastland Technology Australia Pty, Ltd. Syringe or like parenteral device
US5772608A (en) 1994-12-28 1998-06-30 The Research Foundation Of State University Of New York System for sampling arterial blood from a patient
US5811658A (en) 1997-04-29 1998-09-22 Medtronic, Inc. Ultrasonic diversion of microair in blood
US5824001A (en) 1996-06-10 1998-10-20 Becton Dickinson And Company Radially vented flashback chamber and plug assembly
US5857983A (en) 1996-05-17 1999-01-12 Mercury Diagnostics, Inc. Methods and apparatus for sampling body fluid
US5865812A (en) 1995-09-27 1999-02-02 United States Surgical Corporation Fluid flow control apparatus for surgical cannulae
US5871699A (en) 1995-01-10 1999-02-16 Ruggeri; Guido Apparatus and method for drawing liquid samples and dispensing them into a plurality of test tubes
US5876926A (en) 1996-07-23 1999-03-02 Beecham; James E. Method, apparatus and system for verification of human medical data
WO1999010829A1 (en) 1997-08-22 1999-03-04 Deka Products Limited Partnership Health care system and method for physician order entry
WO1999010830A1 (en) 1997-08-22 1999-03-04 Deka Products Limited Partnership Automated health care system
WO1999010029A1 (en) 1997-08-22 1999-03-04 Deka Products Limited Partnership System and method for intelligent admixture and delivery of medications
WO1999013925A1 (fr) 1997-09-12 1999-03-25 Asahi Medical Co., Ltd. Unite de filtrage permettant d'extraire les leucocytes et mode d'utilisation
USD410081S (en) 1997-08-22 1999-05-18 Bridge Medical, Inc. Medication infusion device
US5911705A (en) 1996-04-04 1999-06-15 Becton Dickinson And Company One step catheter advancement automatic needle retraction system
US5922551A (en) 1997-03-20 1999-07-13 Accumetrics, Inc. Agglutrimetric platelet binding assays in blood
US5961472A (en) 1997-09-26 1999-10-05 Baxter International Inc. Closed, one-handed blood sampling system
US5971956A (en) 1997-04-15 1999-10-26 Biosurgical Corporation Medical suctioning apparatus and methods of use
US5980830A (en) 1996-05-20 1999-11-09 Sendx Medical, Inc. Portable modular blood analyzer with simplified fluid handling sequence
US6001307A (en) 1996-04-26 1999-12-14 Kyoto Daiichi Kagaku Co., Ltd. Device for analyzing a sample
US6010633A (en) 1997-03-06 2000-01-04 Hemasure Inc. Method of preventing air from becoming entrapped within a filtration device
US6016712A (en) 1997-09-18 2000-01-25 Accumetrics Device for receiving and processing a sample
US6057105A (en) 1995-03-17 2000-05-02 Ngi/Cancer Tech Company, Llc Detection of melanoma or breast metastasis with a multiple marker assay
WO2000024313A1 (en) 1998-10-26 2000-05-04 Noble House Group Pty Ltd Sampling in blood collection
US6074366A (en) 1998-01-16 2000-06-13 Tandem Medical Inc. Medication delivery apparatus
WO2000041624A1 (en) 1999-01-12 2000-07-20 Elcam Plastic Blood sampling device
US6106509A (en) 1996-02-08 2000-08-22 Loubser; Paul G. Closed circuit autologous sequestration reservoir system
US6126643A (en) 1997-03-06 2000-10-03 Vaillancouert; Vincent L. Blood collecting syringe
DE29913417U1 (de) 1999-08-06 2000-12-28 Zierden, Peter, Dr., 40764 Langenfeld Vorrichtung zur Entnahme von Blut aus einem Blutgefäß
WO2001008546A2 (en) 1999-07-29 2001-02-08 Baxter International Inc. Sampling tube holder for blood sampling system
US6210909B1 (en) 1991-04-18 2001-04-03 Lamina, Inc. Liquid specimen container and attachable testing modules
US6306614B1 (en) 1994-06-08 2001-10-23 Sepsis, Inc. Measurement of analytes in whole blood
US20010039058A1 (en) 1999-05-14 2001-11-08 Iheme Mordi I. Fluid transfer device
US6325975B1 (en) 1997-08-27 2001-12-04 Arkray, Inc. Suction generating device and sample analysis apparatus using the same
US6328726B1 (en) 1998-01-16 2001-12-11 Terumo Kabushiki Kaisha Blood collecting apparatus and blood-collecting method using blood collecting apparatus
US20020002349A1 (en) 1996-10-11 2002-01-03 Transvascular, Inc. Systems and methods for delivering drugs to selected locations within the body
US20020004647A1 (en) 2000-05-02 2002-01-10 Leong Alvin Tan Chee Flashback blood collection needle
US6364890B1 (en) 1999-03-08 2002-04-02 Agilent Technologies, Inc. Extraction and transportation of blood for analysis
US6387086B2 (en) 1999-07-29 2002-05-14 Baxter International Inc. Blood processing set including an integrated blood sampling system
US6403381B1 (en) 1998-06-08 2002-06-11 University Of Vermont And State Agriculture College Inhibition of coagulation in blood and blood products
WO2002051520A1 (en) 2000-12-21 2002-07-04 Hemerus Medical, Llc Biological fluid filter
US20020107469A1 (en) 2000-11-03 2002-08-08 Charles Bolan Apheresis methods and devices
US6482188B1 (en) 1999-10-01 2002-11-19 Mission Medical Devices, Inc. Nonvented needle-free injection valve
US20020183651A1 (en) 2001-05-29 2002-12-05 Hyun Dongchul D. Blood drawing system
US20020193751A1 (en) 1999-10-12 2002-12-19 Felix Theeuwes Regulation of drug delivery through flow diversion
US6506182B2 (en) 1996-06-12 2003-01-14 Biolink Corporation Method for subcutaneous access to the vascular system of a patient
US20030013991A1 (en) 2001-01-23 2003-01-16 Stone Benjamin Curtis Method of body fluid specimen collection
US6511439B1 (en) 1999-12-07 2003-01-28 Terumo Kabushiki Kaisha Blood-collecting device
WO2003008012A2 (de) 2001-07-18 2003-01-30 Hiberna Ag Vorrichtung und verfahren zur blutpräparation
US20030055381A1 (en) 2001-09-17 2003-03-20 Wilkinson Bradley M. Medical devices
US20030069543A1 (en) 2001-07-10 2003-04-10 Carpenter Kenneth W. Sterile aspiration/reinjection systems
US6569117B1 (en) 1999-01-01 2003-05-27 Elcam+Plastic Cooperative Agriculture Association Ltd. Blood sampling/injecting valve
US20030105414A1 (en) 2001-05-02 2003-06-05 Bd Medical Products, Pte. Ltd. Flashback blood collection needle
US6638252B2 (en) 2001-05-25 2003-10-28 Becton Dickinson And Company Cantilever push tab for an intravenous medical device
US20030208151A1 (en) 2000-02-14 2003-11-06 Menachem Kraus Predonation blood sampling apparatus
US6648835B1 (en) 1999-02-24 2003-11-18 Teva Medical Ltd. Fluid sampling apparatus
US6665385B2 (en) 2001-04-23 2003-12-16 Cardionet, Inc. Medical monitoring system having multipath communications capability
US6664893B1 (en) 2001-04-23 2003-12-16 Cardionet, Inc. Method for controlling access to medical monitoring device service
US20040009542A1 (en) 2002-05-03 2004-01-15 Gambro, Inc. Apparatus and method for detecting bacteria in blood products
US20040010228A1 (en) 2001-09-25 2004-01-15 Becton, Dickinson And Company Activation of dual blunting needle assembly
US6695004B1 (en) 2002-12-16 2004-02-24 Alaris Medical Systems, Inc. Magnetic automatic stop valve
US20040054283A1 (en) 2002-08-28 2004-03-18 Scott Corey Apparatus for hematocrit determination and method for its use
DE10243129A1 (de) 2002-09-18 2004-04-01 Ritter Gmbh Mehrfachblutentnahmegerät für Kleintiere und ähnliche Anwendungen
US6733433B1 (en) 1998-12-24 2004-05-11 Biosafe S.A. Blood separation system particularly for concentrating hematopoietic stem cells
US6736783B2 (en) 2000-04-12 2004-05-18 Merck & Co., Inc. Automated blood sampling apparatus
US6746420B1 (en) 1998-12-11 2004-06-08 Dean B. Prestidge Parenteral apparatus
US20040127816A1 (en) 2002-12-30 2004-07-01 Adriano Braun Galvao Handheld blood collection device
US20040147855A1 (en) 2003-01-23 2004-07-29 Becton, Dickinson And Company Coupling device for blood collection assembly
US20050004524A1 (en) 2002-06-07 2005-01-06 Becton, Dickinson And Company Flashback device for venous specimen collection
US6860871B2 (en) 2001-04-30 2005-03-01 Injectimed, Inc. Needle tip guard for percutaneous entry needles
US20050148993A1 (en) 1999-07-29 2005-07-07 Jean-Marie Mathias Method and apparatus for blood sampling
US20050161112A1 (en) 2002-04-09 2005-07-28 Rudolf Ehwald Automatic sample collector
WO2005068011A1 (en) 2004-01-13 2005-07-28 Cell Center Cologne Gmbh An apparatus and a method for controlling a fluid of extracorporeal circulation systems
US20050199077A1 (en) 2004-03-15 2005-09-15 Prybella John R. Closed method and system for the sampling and testing of fluid
US6945948B2 (en) 2000-03-09 2005-09-20 Gambro, Inc. Extra-corporeal dual stage blood processing method and apparatus
US6957107B2 (en) 2002-03-13 2005-10-18 Cardionet, Inc. Method and apparatus for monitoring and communicating with an implanted medical device
US20050240161A1 (en) 2002-05-02 2005-10-27 Becton, Dickinson And Company Needle assembly
US20050245885A1 (en) 2004-05-03 2005-11-03 Leroy Brown Blood drawing device with flash detection
US20050273019A1 (en) 2004-06-02 2005-12-08 Becton, Dickinson And Company Blood collection set with venting mechanism
US20050281713A1 (en) 2004-06-18 2005-12-22 Bioanalytical Systems, Inc. (An Indiana Company) System and method for sample collection
US6979323B2 (en) 2003-02-07 2005-12-27 Aragon Medical Corporation Closed system catheterization assembly and related methods
WO2006031500A2 (en) 2004-09-10 2006-03-23 Becton, Dickinson And Company Reconstituting infusion device
US7052603B2 (en) 2002-06-14 2006-05-30 Scilog, Inc. Single-use manifold for automated, aseptic transfer of soulutions in bioprocessing applications
US20060251622A1 (en) 2003-05-21 2006-11-09 Koji Suzuki Container for serum production and method of regenerative medicine using the same
US7141097B2 (en) 2003-01-15 2006-11-28 Filtertek Inc. Bacterial retentive, air venting, intravenous filter
US20060287639A1 (en) 2005-06-15 2006-12-21 Inviro Medical Devices Ltd. Safety fluid transfer cannula
CN1901955A (zh) 2003-11-21 2007-01-24 瓦索根爱尔兰有限公司 医疗材料处理系统
WO2007033319A1 (en) 2005-09-13 2007-03-22 Edwards Lifesciences Corporation Closed blood sampling system with isolated pressure monitoring
US20070088279A1 (en) 2005-07-26 2007-04-19 Ming-Jeng Shue Intravenous catheter introducing device with a tubular outlet member
US20070100250A1 (en) 2003-02-14 2007-05-03 The Charlotte-Mecklenburg Hospital Authority Device and method for collection of exhaled alveolar breath condensate
US20070119508A1 (en) 2005-11-29 2007-05-31 West Richard L Fluid Flow Diversion Valve and Blood Collection System Employing Same
US7241281B2 (en) 2002-04-08 2007-07-10 Thermogenesis Corporation Blood component separation method and apparatus
US7306736B2 (en) 2000-12-08 2007-12-11 Nephros, Inc. Valve mechanism for infusion fluid systems
US20070287948A1 (en) 2006-06-07 2007-12-13 Paul Sakiewicz Method and device for reversing lines in the procedure of hemodialysis
US7314452B2 (en) 2005-01-10 2008-01-01 Edwards Lifesciences Corporation Self flushing luer activated blood sampling devices
US7316662B2 (en) 2002-07-09 2008-01-08 Gambro Lundia Ab Infusion device for medical use
US7335188B2 (en) 2004-06-12 2008-02-26 Graf Christian D Lumbar puncture fluid collection device
US7351228B2 (en) 2003-11-06 2008-04-01 Becton, Dickinson And Company Plunger rod for arterial blood collection syringes
US20080086085A1 (en) 2004-05-03 2008-04-10 Leroy Brown Blood drawing device with flash detection
US20080108954A1 (en) 2006-11-02 2008-05-08 Jean-Marie Mathias Flow Controllers
US7384416B2 (en) 2002-08-12 2008-06-10 Macopharma Device and method for irreversible closure of fluid communication in a container system
US20080167577A1 (en) 2006-12-29 2008-07-10 Weilbacher Eugene E Vented phlebotomy needle with flashback chamber
US20080185056A1 (en) 2007-02-01 2008-08-07 Saint-Gobain Performance Plastics Corporation Connector assembly
WO2008101025A1 (en) 2007-02-15 2008-08-21 Edwards Lifesciences Corporation Disposable, closed blood sampling system for use in medical conduit line
US20080254471A1 (en) 2005-10-13 2008-10-16 Alamo Scientific Apparatus and Method for Microbial and Forensic Sampling and Manipulation
US20080319346A1 (en) 2007-03-07 2008-12-25 Becton, Dickinson And Company Safety Blood Collection Assembly With Indicator
US7479131B2 (en) 1999-07-29 2009-01-20 Fenwal, Inc. Biological fluid sampling apparatus, assembly and method
US20090050213A1 (en) 2005-05-03 2009-02-26 Sartorius Stedim Biotech Gmbh Connector, Connector System and Use Thereof
US20090192447A1 (en) 2008-01-25 2009-07-30 Smiths Medical Asd, Inc. Gas vent valve assembly
US7614857B2 (en) 2001-11-16 2009-11-10 Medinnovation Ag Medical pump device
US7615033B2 (en) 2004-08-16 2009-11-10 Becton, Dickinson And Company Flashback blood collection needle
US7618407B2 (en) 2003-02-19 2009-11-17 Macopharma Bag system with device for associating sampling receptacles
US20090306601A1 (en) 2008-06-10 2009-12-10 Shaw Thomas J Fluid Flow Control Device with Retractable Cannula
US20100010372A1 (en) 2004-05-03 2010-01-14 Clearview Patient Safety Technologies, Llc Porous multiple sample sleeve and blood drawing device for flash detection
US7648491B2 (en) 2005-05-13 2010-01-19 Bob Rogers Medical substance transfer system
US20100042048A1 (en) 2008-08-15 2010-02-18 Becton, Dickinson And Company Luer Integrated Air Venting System
US7666166B1 (en) 2004-12-27 2010-02-23 Blivic, Llc Bloodless intravenous integrated catheter
US20100057004A1 (en) 2006-10-05 2010-03-04 Becton, Dickinson And Company Extravascular System In-Line Venting
US20100152681A1 (en) 2002-01-31 2010-06-17 Jean-Marie Mathias Irreversible flow control clamp
US7766879B2 (en) 2008-03-07 2010-08-03 Becton, Dickinson And Company Flashback blood collection needle
US7780794B2 (en) 2006-07-21 2010-08-24 Ivera Medical Corporation Medical implement cleaning device
US20100268118A1 (en) 2007-09-27 2010-10-21 Gerd Schweiger System for removal and infusion of body fluid, and method for its operation
US20100306938A1 (en) 2009-06-01 2010-12-09 Ivera Medical Corporation Medical implement cleaning device with friction-based fitting
WO2011030282A1 (en) 2009-09-09 2011-03-17 Poly Medicure Limited Blood collection device
WO2011069145A2 (en) 2009-12-04 2011-06-09 Becton, Dickinson And Company Blood collection tube with separation barrier
US20110232020A1 (en) 2010-03-26 2011-09-29 Ivera Medical Corporation Medical implement cleaning device with friction-based fitting and energy directors
US20120004619A1 (en) 2010-03-31 2012-01-05 Stephens John D Needle protective device
WO2012012127A2 (en) 2010-06-30 2012-01-26 Hoyle John D Jr Dosage control syringe
US20120035540A1 (en) 2006-04-12 2012-02-09 Searete Llc, A Limited Liability Corporation Of The State Of Delaware Event-based control of a lumen traveling device
US8197420B2 (en) 2006-12-18 2012-06-12 Magnolia Medical Technologies, Inc. Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination
US20120216359A1 (en) 2011-02-18 2012-08-30 Ivera Medical Corporation Medical Implement Cleaning System
US8287499B2 (en) 2010-04-30 2012-10-16 Tyco Healthcare Group Lp Syringe and catheter set comprising same
US20120265128A1 (en) 2009-12-11 2012-10-18 Harm Kolln Continuously Conveying Infusion Pump
US20120265099A1 (en) 2011-04-12 2012-10-18 Goodnow Ii James E Systems and Methods for Managing Blood Donations
US8349254B2 (en) 2005-07-08 2013-01-08 Terumo Kabushiki Kaisha Circuit for collecting blood component and apparatus for collecting blood component
US8377040B2 (en) 2006-11-06 2013-02-19 Becton, Dickinson And Company Extravascular system venting
US8382712B2 (en) 2009-02-09 2013-02-26 E-Wha Fresenius Kabi Inc. Filter device and liquid injection apparatus having the same
US8383044B2 (en) 2009-07-09 2013-02-26 Becton, Dickinson And Company Blood sampling device
US8412300B2 (en) 2009-02-12 2013-04-02 Becton, Dickinson And Company Arterial flashback confirmation chamber
US8523826B2 (en) 2009-02-13 2013-09-03 Cytyc Corporation Luer-type needle-free valve fitting with bypass
US8535241B2 (en) 2011-10-13 2013-09-17 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US8540663B2 (en) 1998-02-24 2013-09-24 Navilyst Medical, Inc. High flow rate dialysis catheters and related methods
US8568371B2 (en) 2009-06-22 2013-10-29 Np Medical Inc. Medical valve with improved back-pressure sealing
US8574203B2 (en) 2009-02-11 2013-11-05 Becton, Dickinson And Company Systems and methods for providing a flushable catheter assembly
US8603009B2 (en) 2008-03-07 2013-12-10 Becton, Dickinson And Company Flashback blood collection needle
US20130335195A1 (en) 2012-06-18 2013-12-19 Bobby E. Rogers Source and Destination Lighted Indicator for Medical Fluid Lines
US20140066880A1 (en) 2011-06-22 2014-03-06 Crisi Medical Systems, Inc. Selectively Controlling Fluid Flow Through A Fluid Pathway
US20140150832A1 (en) 2012-06-04 2014-06-05 Bobby E. Rogers Male medical implement cleaning device
US8795198B2 (en) 2008-03-07 2014-08-05 Becton, Dickinson And Company Flashback blood collection needle
US8827958B2 (en) 2009-05-12 2014-09-09 Access Scientific, Llc Access device with valve
US8832894B2 (en) 2011-07-19 2014-09-16 Ivera Medical Corporation Cleaning device for male end of intraveneous set
US20140261581A1 (en) 2013-03-15 2014-09-18 Ivera Medical Corporation Medical Implement Cleaning Device
US20140261558A1 (en) 2010-04-30 2014-09-18 Ivera Medical Corporation Female luer connector disinfecting cap
US8864684B2 (en) 2011-10-13 2014-10-21 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US20150018715A1 (en) 2013-03-19 2015-01-15 Juan Nepomuc Walterspiel Devices and Methods to Reduce Contamination of Fluid Collected from a Patient
EP2854643A1 (en) 2012-05-30 2015-04-08 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US9022950B2 (en) 2012-05-30 2015-05-05 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US9138572B2 (en) 2010-06-24 2015-09-22 Np Medical Inc. Medical valve with fluid volume alteration
US9149576B2 (en) 2012-10-11 2015-10-06 Magnolia Medical Technologies, Inc. Systems and methods for delivering a fluid to a patient with reduced contamination
US9155495B2 (en) 2012-11-30 2015-10-13 Magnolia Medical Technologies, Inc. Syringe-based fluid diversion mechanism for bodily fluid sampling
US20150342510A1 (en) 2012-12-04 2015-12-03 Magnolia Medical Technologies, Inc. Sterile bodily-fluid collection device and methods
US9204864B2 (en) 2012-08-01 2015-12-08 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US20150359473A1 (en) 2014-06-13 2015-12-17 Chad Garrett Catheter Insertion Device with Blood Analyzer
WO2016054252A1 (en) 2014-09-30 2016-04-07 Exosome Diagnostics, Inc. Apparatuses, methods, and systems for sample collection and dispersion
US9314201B2 (en) 2010-07-15 2016-04-19 Becton, Dickinson And Company Removable flash chamber
US20160174888A1 (en) 2014-08-01 2016-06-23 Tasso, Inc. Devices, systems and methods for gravity-enhanced microfluidic collection, handling and transferring of fluids
US20160361006A1 (en) 2015-06-12 2016-12-15 Magnolia Medical Technologies, Inc. Devices and methods for syringe-based fluid transfer for bodily-fluid sampling
US20160367177A1 (en) 2015-06-19 2016-12-22 Becton, Dickinson And Company Biological Fluid Collection Device
US20170020427A1 (en) 2015-07-24 2017-01-26 Calliope Solutions, Inc. Blood sample optimization system and blood contaminant sequestration device and method
WO2017041087A1 (en) 2015-09-03 2017-03-09 Bullington Gregory J Apparatus and methods for maintaining sterility of a specimen container
US20170071519A1 (en) 2013-04-15 2017-03-16 Becton, Dickinson And Company Biological Fluid Collection Device and Biological Fluid Separation and Testing System
US20170361019A1 (en) 2016-06-15 2017-12-21 Michael Hopkins Syringe systems and methods for multi-stage fluid delivery
US9855386B2 (en) 2012-12-31 2018-01-02 Medtg, Llc Infusion and blood collection device and method
US9895092B2 (en) 2010-07-15 2018-02-20 Becton, Dickinson And Company Vented blood sampling device
US20180093077A1 (en) 2014-04-18 2018-04-05 Becton, Dickinson And Company Multi-use blood control safety catheter assembly
US20180160958A1 (en) 2012-03-07 2018-06-14 Poly Medicure Limited Blood collection device
US20180177445A1 (en) 2016-12-27 2018-06-28 Kurin, Inc. Blood sample optimization system and blood contaminant sequestration device and method
US20180271425A1 (en) 2017-02-10 2018-09-27 Kurin, Inc. Blood contaminant sequestration device with one-way air valve and air-permeable blood barrier with closure mechanism
US20180353117A1 (en) 2017-06-09 2018-12-13 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US20190030293A1 (en) 2017-07-25 2019-01-31 Kurin, Inc. Needle assembly with needle safety shield
US10251590B2 (en) 2012-12-04 2019-04-09 Magnolia Medical Technologies, Inc. Sterile bodily-fluid collection device and methods
US20190175087A1 (en) 2017-12-07 2019-06-13 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US20190365303A1 (en) 2018-05-31 2019-12-05 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US20200281514A1 (en) 2017-02-10 2020-09-10 Kurin, Inc. Blood contaminant sequestration device with passive fluid control junction
US20200305780A1 (en) 2019-04-01 2020-10-01 Kurin, Inc. Non-venting bodily fluid sample optimization device and system

Family Cites Families (103)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1590199A (zh) 1968-10-10 1970-04-13
US3596652A (en) 1968-10-14 1971-08-03 Bio Science Labor Fluid separatory device
US3640267A (en) 1969-12-15 1972-02-08 Damon Corp Clinical sample container
FR2110516A5 (en) 1970-10-20 1972-06-02 Blanchet Henry Two compartment automatic syringe - for multiple inoculation
US3831602A (en) 1972-02-11 1974-08-27 Union Plastics Corp Adjustable syringe assemblies
US3859998A (en) 1972-06-05 1975-01-14 Johnson & Johnson Intravenous needle assembly
US3996923A (en) 1973-03-23 1976-12-14 Guerra Luis A Blood taking device
US3960139A (en) 1975-01-15 1976-06-01 Bailey Donald L Syringe device with means for removing contaminates when drawing blood sample
US4210173A (en) 1976-12-06 1980-07-01 American Hospital Supply Corporation Syringe pumping system with valves
US4354507A (en) 1978-01-17 1982-10-19 Concord Laboratories Syringe
DE2946660A1 (de) 1979-03-07 1981-05-27 C.A. Greiner und Söhne GmbH & Co KG, 7440 Nürtingen Blutentnahmegeraet
US4312362A (en) * 1980-10-02 1982-01-26 Becton, Dickinson And Company Single sample needle with vein entry indicator
US4436098A (en) 1981-03-16 1984-03-13 Becton Dickinson Company Needle assembly with vein entry indicator
US4416291A (en) 1981-07-20 1983-11-22 Becton Dickinson And Company Multiple sample needle assembly with vein entry indicator
US4373535A (en) 1981-08-17 1983-02-15 Martell Michael D Venting, self-stopping, aspirating syringe
US4411275A (en) 1981-11-02 1983-10-25 Concord Laboratories, Inc. Syringe
US4699612A (en) 1985-04-01 1987-10-13 Hamacher Edward N Infusion needle
US4690154A (en) 1985-06-03 1987-09-01 Timothy Woodford Vented syringe
US4626248A (en) 1985-12-16 1986-12-02 Storz Instrument Company Ophthalmic cassette
US4715854A (en) 1986-07-17 1987-12-29 Vaillancourt Vincent L Multidose disposable syringe and method of filling same
US4838855A (en) 1987-07-31 1989-06-13 Lynn Lawrence A Blood aspiration assembly and method
US5052403A (en) 1989-12-29 1991-10-01 Habley Medical Technology Corporation Self-contained, safety blood collection system
US5395339A (en) 1992-01-31 1995-03-07 Sherwood Medical Company Medical device with sterile fluid pathway
CN2115767U (zh) 1992-03-21 1992-09-16 郑铁生 负压式两用抽血器
US5354537A (en) 1992-04-27 1994-10-11 Akzo N.V. Piercing and sampling probe
GB9220597D0 (en) 1992-09-30 1992-11-11 Boyde Thomas Multilocular sample containers for blood or other fluids
US5334162A (en) 1993-03-15 1994-08-02 Eli Lilly And Company Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same
AT400802B (de) 1993-12-16 1996-03-25 Greiner & Soehne C A Haltevorrichtung für ein blutprobenentnahmeröhrchen einer blutabnahmevorrichtung
US5522804A (en) 1994-02-15 1996-06-04 Lynn; Lawrence A. Aspiration, mixing, and injection syringe
US5577513A (en) 1994-08-31 1996-11-26 Activated Cell Therapy, Inc. Centrifugation syringe, system and method
US5785682A (en) 1995-03-22 1998-07-28 Abbott Laboratories Pre-filled syringe drug delivery system
US5759160A (en) 1995-11-20 1998-06-02 Utah Medical Products, Inc. Blood sampling system
GB2350317B (en) 1996-07-15 2001-01-10 Star Syringe Ltd Apparatus for making syringes
US6013037A (en) 1997-02-07 2000-01-11 Vascular Logics, Inc. Syringe with conduit
US5873841A (en) 1997-02-07 1999-02-23 Vascular Logics, Inc. Syringe with decelerating device
WO1998046136A1 (fr) 1997-04-15 1998-10-22 Debiotech S.A. Seringue a compartiments multiples
WO1999033559A1 (en) * 1997-12-24 1999-07-08 Cepheid Integrated fluid manipulation cartridge
IES980225A2 (en) 1998-03-25 1999-10-20 Provost A device for acquiring body samples for analysis
US6086545A (en) 1998-04-28 2000-07-11 Amira Medical Methods and apparatus for suctioning and pumping body fluid from an incision
US6050957A (en) 1998-07-01 2000-04-18 Desch; Larry W. Multiple-draw, variable suction syringe
US6254581B1 (en) 1998-09-18 2001-07-03 Creighton University Pleural cavity drainage device
US6716187B1 (en) 1999-07-08 2004-04-06 Implant Innovations, Inc. Platelet concentration syringe kit
US6364847B1 (en) 1999-10-07 2002-04-02 Sunscope International, Inc. Blood sampling device
US6355023B1 (en) 1999-11-15 2002-03-12 Gaylord Hospital Closed system access device
IL136512A0 (en) * 2000-06-01 2001-06-14 Medivice Systems Ltd Intravenous infusion administration set
US6592555B1 (en) 2000-06-23 2003-07-15 Wang Wen-Pi Syringe device
US6478775B1 (en) 2000-10-02 2002-11-12 Genyx Medical Inc. Device for delivering non-biodegradable bulking composition to a urological site
JP2002116201A (ja) 2000-10-11 2002-04-19 Sekisui Chem Co Ltd 細胞機能測定容器
FR2833175B1 (fr) 2001-12-06 2004-05-14 Sobem Dispositif de controle de debit, a usage medical
AU2003220295B2 (en) 2002-03-14 2007-10-18 Fenwal, Inc. Biological fluid sampling apparatus
CA2503156A1 (en) 2002-10-29 2004-05-13 Vasogen Ireland Limited Device and method for controlled expression of gases from medical fluids delivery systems
US20050154368A1 (en) 2003-11-21 2005-07-14 Vasogen Ireland Limited Medical material handling systems
JP4573538B2 (ja) 2004-02-26 2010-11-04 株式会社ジェイ・エム・エス 体液採取装置
US7896817B2 (en) 2005-08-05 2011-03-01 Devicor Medical Products, Inc. Biopsy device with manually rotated sample barrel
EP1945100A2 (en) 2005-09-15 2008-07-23 Situgen Ltd. Apparatus and method for collecting cord blood
US20070083162A1 (en) 2005-10-11 2007-04-12 Span-America Medical Systems, Inc. Valve for intravenous catheter
EP1980204A4 (en) 2006-01-31 2015-07-29 Panasonic Healthcare Holdings Co Ltd BLOOD ANALYSIS METHOD AND BLOOD ANALYSIS APPARATUS
US8206318B2 (en) 2006-03-22 2012-06-26 Panasonic Corporation Blood test apparatus
US11906512B2 (en) 2006-03-31 2024-02-20 Zeus Diagnostics, LLC Integrated device for analyte testing, confirmation, and donor identity verification
US9320459B2 (en) 2006-05-08 2016-04-26 Becton, Dickinson And Company Gravity-drop safety holder
JP4869910B2 (ja) 2006-11-08 2012-02-08 川澄化学工業株式会社 液体貯留容器、液体採取器具及び採血器具
ITPD20060419A1 (it) 2006-11-13 2008-05-14 Federico Nalesso Dispositivo per il trattamento manutentivo di cateteri venosi centrali
US8034033B2 (en) 2007-04-13 2011-10-11 Yair Grinberg Hypodermic syringe with vial attachment
US8349554B2 (en) 2007-08-14 2013-01-08 Fred Hutchinson Cancer Research Center Needle array assembly and method for delivering therapeutic agents
US20090076441A1 (en) 2007-08-15 2009-03-19 Eric Sebban Aspirator assembly
EP2237821A1 (en) 2008-01-23 2010-10-13 Mallinckrodt Inc. Plunger adapter coaxial syringe system
US20090301317A1 (en) 2008-06-04 2009-12-10 Eieio, Inc. Method and System for Dispensing Whipped Toppings
US8356644B2 (en) 2009-08-07 2013-01-22 Medtronic Minimed, Inc. Transfer guard systems and methods
CN102802525B (zh) 2010-03-15 2015-01-07 松村鹰仁 真空采血管,采血单元
EP2555825B1 (en) 2010-04-05 2022-06-22 Daniel Py Aseptic fluid connector with deflecting members and method comprising the use of such a connector
EP2665502B1 (en) 2011-01-17 2020-03-25 AktiVax, Inc. Aseptic cartridge and dispenser arrangement
GB201103068D0 (en) 2011-02-22 2011-04-06 The Technology Partnership Aseptic sampling system
US9295788B2 (en) 2011-03-04 2016-03-29 Anestaweb, Inc. Syringe with integrated cannula
US8992505B2 (en) 2011-04-18 2015-03-31 Thorne Consulting & Intellectual Property, LLC Medical syringe filling and valving
US20130158506A1 (en) 2011-05-19 2013-06-20 Tangent Medical Technologies Llc Catheter and needle system and method of inserting a catheter
US20130085514A1 (en) 2011-09-30 2013-04-04 Tyco Healthcare Group Lp Rotating occlusion treatment system
DE102012202197B3 (de) 2012-02-14 2013-04-18 Siemens Aktiengesellschaft Blutentnahmeröhrchen mit integrierter Sensoreinrichtung
WO2013137359A1 (ja) 2012-03-14 2013-09-19 テルモ株式会社 検査用血液容器および採血器具
EP2887991B1 (en) 2012-08-21 2022-11-02 Optomeditech Oy Intravascular catheter assembly
US10105085B2 (en) 2012-11-03 2018-10-23 ProVazo LLC Directing hub used with vascular blood sampling catheter
US9233208B2 (en) 2012-11-29 2016-01-12 Becton, Dickinson And Company Methods and apparatus for disinfecting and reflux prevention flush syringe assembly
US9945839B2 (en) 2012-11-30 2018-04-17 Rarecyte, Inc. Apparatus, system, and method for collecting a target material
ES2817790T3 (es) 2013-05-15 2021-04-08 Becton Dickinson Co Reguladores de presión de vacío para uso durante recogida de sangre
JP6166606B2 (ja) 2013-07-08 2017-07-19 株式会社呼気生化学栄養代謝研究所 終末呼気採取装置
EP3021917B1 (en) 2013-07-16 2018-01-31 UNL Holdings LLC Syringes for prefilled and fill-at-use mixing and drug delivery
FR3008744A1 (fr) 2013-07-22 2015-01-23 Eveon Sous-ensemble oscillo-rotatif et dispositif de pompage volumetrique oscillo-rotatif pour pompage volumetrique d'un fluide
US10123783B2 (en) 2014-03-03 2018-11-13 Magnolia Medical Technologies, Inc. Apparatus and methods for disinfection of a specimen container
CN105090005B (zh) 2014-04-29 2017-04-19 南京德朔实业有限公司 流体泵及其组成的泵油装置
US10112033B2 (en) 2014-07-08 2018-10-30 Becton, Dickinson And Company Intravenous needle assembly having blood dispensing capabilities
KR20180108649A (ko) 2016-01-06 2018-10-04 레아플릭스 에이피에스 차후의 자가 사용을 위한 응혈 촉진 인자
CN109952313B (zh) 2016-01-15 2023-12-19 伯克利之光生命科技公司 生产患者特异性抗癌治疗剂的方法和其治疗方法
SE539853C2 (en) * 2016-02-03 2017-12-19 Hemcheck Sweden Ab An arrangement for collection and separation of a body fluid for purposes of analysis and a method relating thereto
US11167085B2 (en) 2016-06-15 2021-11-09 True Concepts Medical Technologies, Llc Syringe systems and methods for multi-stage fluid delivery
US10238326B2 (en) 2016-08-04 2019-03-26 Elcam Medical Agricultural Cooperative Association Ltd. Flushable fluid handling assembly
EP3541284B1 (en) 2016-11-18 2023-02-22 Magnolia Medical Technologies, Inc. Device for blood sample collection with reduced hemolysis
US10480117B2 (en) 2017-02-27 2019-11-19 Whirlpool Corporation Self cleaning sump cover
CA3064778A1 (en) 2017-06-08 2018-12-13 Becton, Dickinson And Company Biological fluid separation device
US11213232B2 (en) 2017-07-17 2022-01-04 Becton Dickinson And Company Device for trapping an initial flow of blood
IL273025B1 (en) 2017-09-12 2024-08-01 Magnolia Medical Technologies Inc Fluid control devices and methods for their use
EP3813668B1 (en) 2018-06-08 2024-09-11 Smiths Medical ASD, Inc. Blood sequestration device
AU2020218544A1 (en) 2019-02-08 2021-09-16 Magnolia Medical Technologies, Inc. Devices and methods for bodily fluid collection and distribution
EP4265186A3 (en) 2019-03-11 2024-01-17 Magnolia Medical Technologies, Inc. Fluid control devices
US12129588B2 (en) 2021-11-18 2024-10-29 Haier Us Appliance Solutions, Inc. Systems and methods for monitoring turn-over performance

Patent Citations (355)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2707953A (en) 1952-07-15 1955-05-10 Abbott Lab Transfusion equipment
US3013557A (en) 1959-04-13 1961-12-19 Hazleton Lab Inc Combination syringe, shipping container and centrifuge tube
US2992974A (en) 1960-04-04 1961-07-18 Allan S Belcove Biological testing device
US3098016A (en) 1961-07-26 1963-07-16 American Cyanamid Co Process for producing sterile vials containing culture media and a carbon dioxide atmosphere
US3405706A (en) 1965-04-22 1968-10-15 Cinqualbre Paul Arrangement for taking blood
US3382865A (en) 1965-10-18 1968-05-14 Ashton L. Worrall Jr. Device for taking multiple blood samples or the like
US3494351A (en) 1966-06-21 1970-02-10 Ferrell S Horn Multiple vial fluid collecting device
US3467095A (en) 1967-04-24 1969-09-16 Eugene Ross Lab Inc Blood collection set
US3467021A (en) * 1968-02-12 1969-09-16 Mec O Matic Inc Fluid pressure operated pump
US3577980A (en) 1968-05-28 1971-05-11 Milton J Cohen Fluid extraction device
US3604410A (en) 1968-09-11 1971-09-14 Gary L Whitacre Multitube blood sampler
US3635798A (en) 1969-03-24 1972-01-18 William R Kirkham Blood and fluid culturing system
US3494352A (en) 1969-03-26 1970-02-10 Becton Dickinson Co Apparatus for taking multiple samples
US3680558A (en) 1970-05-27 1972-08-01 Robert F Kapelowitz Syringe with multiple compartments
US3648684A (en) 1970-08-04 1972-03-14 Cleora W Barnwell Device for the direct transfer of blood from a human to culture bottles
US3741197A (en) 1970-09-04 1973-06-26 Micromedia Syst Inc Percussion apparatus for blood sampling
US3730168A (en) 1970-09-10 1973-05-01 Kendall & Co Manometer
US3886930A (en) 1971-04-30 1975-06-03 Abbott Lab Blood collecting assembly
US3890968A (en) 1971-06-25 1975-06-24 Sci Systems Inc Fluid flow control means
US3848581A (en) 1971-10-08 1974-11-19 L Cinqualbre Apparatus for taking multiple samples of biological liquid
JPS4846180A (zh) 1971-10-08 1973-07-02
DE7203008U (de) 1971-11-05 1972-05-10 Immuno Ag Fuer Chem-Med Prod Kombiniertes blutabnahme- und infusionsgeraet
DE2203858B2 (de) 1971-11-05 1977-10-27 Immuno AG für chemisch-medizinische Produkte, Wien Blutabnahme- und reinfusionsgeraet
US3890203A (en) 1972-01-06 1975-06-17 Becton Dickinson Co Method and apparatus for the collection, cultivation and identification of microorganisms from body fluid
US3777773A (en) 1972-02-22 1973-12-11 Koehring Co Pressure compensating valve mechanism
US3803810A (en) 1972-05-01 1974-04-16 Pall Corp Liquid-gas separator and filter
US3817240A (en) 1972-06-28 1974-06-18 Becton Dickinson Co Multiple sample needle assembly with one-way valve and blood flow indicator
US3874367A (en) 1972-06-29 1975-04-01 Becton Dickinson Co Valved blood sampling needle assembly
US3937211A (en) 1972-10-27 1976-02-10 Fa. Walter Sarstedt Kunststoff-Spritzgusswerk Multi-purpose syringe
US3835835A (en) 1972-11-07 1974-09-17 Richardson Merrell Inc Two compartment locking sampling syringe
US3834372A (en) 1973-01-12 1974-09-10 S Turney Disposable manifold with atmospheric vent
US3848579A (en) 1973-02-23 1974-11-19 Real A Villa Automatic elasto-valvular hypodermic sampling needle
US3945380A (en) 1974-08-21 1976-03-23 Cutter Laboratories, Inc. Plasmapheresis assembly
US4057050A (en) 1974-11-29 1977-11-08 Sarstedt W Devices for extracting blood
US3978846A (en) 1975-01-02 1976-09-07 Bailey Donald L Syringe for taking blood samples
DE2541494A1 (de) 1975-08-18 1977-03-31 Guerra Luis A Blutentnahmevorrichtung
US4063460A (en) 1975-08-28 1977-12-20 Jan Axel Svensson Method for evacuating and then collecting medium samples in containers sealed by a resilient stopper at substantially atmospheric pressure
US4077395A (en) 1975-10-15 1978-03-07 St. Thomas's Hospital Medical School Apparatus for taking blood samples from a living patient
US4056101A (en) 1976-09-01 1977-11-01 Baxter Travenol Laboratories, Inc. Means for reducing tissue thromboplastin in collected blood
US4106497A (en) 1977-02-04 1978-08-15 Becton, Dickinson And Company Multiple sample needle assembly with indicator means
US4133863A (en) 1977-03-23 1979-01-09 Sherwood Medical Industries, Inc. Collection tube assembly and method for collecting biological fluids
US4133304A (en) * 1977-04-29 1979-01-09 Emde Corporation Syringe-like apparatus with removable capillary cartridge
US4166450A (en) 1977-07-22 1979-09-04 Metatech Corporation Device and procedure for collecting a succession of intravenous blood samples
US4154229A (en) 1977-08-10 1979-05-15 Becton, Dickinson And Company Blood collection system with venipuncture indicator
US4150089A (en) 1977-09-06 1979-04-17 Linet Michael S Multi-chamber test tube
US4190426A (en) 1977-11-30 1980-02-26 Baxter Travenol Laboratories, Inc. Gas separating and venting filter
US4212308A (en) 1977-12-27 1980-07-15 Becton, Dickinson And Company Parallel-flow one-way blood sampling device
US4349035A (en) 1978-03-14 1982-09-14 Johnson & Johnson Blood collection assembly with unidirectional flow valve
US4207870A (en) * 1978-06-15 1980-06-17 Becton, Dickinson And Company Blood sampling assembly having porous vent means vein entry indicator
US4193400A (en) 1978-06-16 1980-03-18 The Deseret Company Intravenous needle assembly with air bleed plug
US4238207A (en) 1979-01-11 1980-12-09 Baxter Travenol Laboratories, Inc. Method of mounting a filter membrane
US4298358A (en) 1979-01-11 1981-11-03 Baxter Travenol Laboratories, Inc. Gas separating and venting filter
US4257416A (en) 1979-05-03 1981-03-24 David Prager Multi-channel venipuncture infusion set
US4275730A (en) 1979-11-05 1981-06-30 Becton, Dickinson And Company Syringe with pressure-limited delivery
US4340067A (en) 1980-03-31 1982-07-20 Rattenborg Christen C Blood collection syringe
US4340068A (en) 1980-06-18 1982-07-20 Becton, Dickinson And Company Multiple sample needle with vein entry indicator
US4370987A (en) 1980-10-07 1983-02-01 Seymour Bazell Medical fluid collection device
US4412548A (en) 1981-07-30 1983-11-01 Becton Dickinson And Company Multiple sample needle assembly
US4398544A (en) 1981-10-15 1983-08-16 Becton Dickinson And Company Single and multiple sample needle assembly with vein entry indicator
US4459997A (en) 1981-11-03 1984-07-17 Walter Sarstedt Kunststoff-Spritzgusswerk Blood extracting and centrifuging device
US4425235A (en) 1982-03-22 1984-01-10 Sherwood Medical Company Blood collection device with phase partitioning means
US4444203A (en) 1982-03-26 1984-04-24 Lab-A-Cath, Inc. Intravenous catheter placing and specimen gathering device
US4509534A (en) 1982-06-14 1985-04-09 Tassin Jr Myron J Blood withdrawal apparatus and method of using same
US4416290A (en) 1982-08-30 1983-11-22 Becton Dickinson And Company Multiple sample needle assembly with vein indication
US4886072A (en) 1983-12-16 1989-12-12 Becton, Dickinson And Company Multiple sample needle assembly with vein indicator
US4657027A (en) 1984-02-04 1987-04-14 Ferring Biotechnik Gmbh Means for taking blood samples for the diagnosis of bodily functions
US5009847A (en) 1984-06-22 1991-04-23 Solomons Clive C Kit for determining blood platelet stress
US4608996A (en) 1984-08-10 1986-09-02 Cordis Corporation External blood parameter diagnostic system
US4679571A (en) 1984-08-31 1987-07-14 Becton, Dickinson And Company Blood sample needle assembly with vein indicator
US4657160A (en) 1984-09-13 1987-04-14 Andy Woods Pressure infusion control
US4879098A (en) 1985-01-25 1989-11-07 Becton, Dickinson And Company Device for the separation of the lighter fraction from the heavier fraction of a liquid sample
WO1986005568A1 (en) 1985-03-15 1986-09-25 Jan Axel Svensson Slide valve and coupler assembly
US4705497A (en) 1985-05-31 1987-11-10 Terumo Kabushiki Kaisha Blood reservoir
US5108927A (en) 1985-09-04 1992-04-28 Wadley Technologies, Inc. Specimen transport device containing a specimen stabilizing composition
US4654027A (en) 1985-10-30 1987-03-31 Dragan William B Vascular dilating device
US4714461A (en) 1985-11-07 1987-12-22 Becton, Dickinson And Company Catheter assembly with air purging feature
US4772273A (en) 1985-12-13 1988-09-20 Becton, Dickinson And Company Variable-volume vented container
US4673386A (en) 1986-03-06 1987-06-16 Gordon Mark G Blood sampler device
US4676256A (en) 1986-03-24 1987-06-30 Golden Theodore A Hypodermic device
US5045185A (en) 1986-11-10 1991-09-03 Terumo Kabushiki Kaisha Blood separator for separating blood components from a blood bag into separation bags
US4980297A (en) 1987-02-27 1990-12-25 Becton, Dickinson And Company Device for the membrane separation of the components of a liquid sample
US4865583A (en) 1987-05-04 1989-09-12 Tu Ho C Combination blood sampling and intravenous infusion apparatus and method
US4890627A (en) 1987-11-09 1990-01-02 Habley Medical Technology Corporation Manually evacuated suction tube
US5135489A (en) 1988-01-25 1992-08-04 Baxter International Inc. Pre-slit injection site and tapered cannula
US5100394A (en) 1988-01-25 1992-03-31 Baxter International Inc. Pre-slit injection site
US4904240A (en) 1988-06-09 1990-02-27 Hoover Rocklin L Method and apparatus for starting intravenous solutions
WO1990004351A1 (en) 1988-10-20 1990-05-03 Lineback Paul I Methods and apparatus for obtaining arterial blood samples
US4988339A (en) 1988-12-30 1991-01-29 Vadher Dinesh L Retractable needle/syringe devices for blood collection, catheterization, and medicinal injection procedures
US5066284A (en) 1989-05-11 1991-11-19 Becton, Dickinson And Company Vent for flashback plug
US5269317A (en) 1989-06-08 1993-12-14 Bennett Scientific, Inc. Intravenous blood sampling apparatus
US5027827A (en) 1990-03-28 1991-07-02 Cody Michael P Vacuum biopsy apparatus
EP0448795A2 (en) 1990-03-29 1991-10-02 Becton, Dickinson and Company Compartmental body fluid collection tube
US5006114A (en) 1990-04-20 1991-04-09 Rogers Bobby E Medical valve assembly
US5122129A (en) 1990-05-09 1992-06-16 Olson Donald J Sampler coupler device useful in the medical arts
WO1991018632A1 (en) 1990-05-25 1991-12-12 St. Jude Medical, Inc. Fluid control valve
US5084034A (en) 1990-06-08 1992-01-28 Tufts University Method for sampling body fluids
US5097842A (en) 1990-07-23 1992-03-24 Bonn Gina B Device for withdrawing fluids
US5222502A (en) 1990-09-26 1993-06-29 Terumo Kabushiki Kaisha Blood collecting needle
US5032116A (en) 1991-01-09 1991-07-16 Becton, Dickinson And Company Flashback plug
US5116323A (en) 1991-01-22 1992-05-26 Becton, Dickinson And Company Arterial catheter
US5466228A (en) 1991-01-25 1995-11-14 California State University, Fresno Foundation Fluid control apparatus
WO1992016144A1 (en) 1991-03-15 1992-10-01 Goldspill Pty. Ltd. Body fluid extraction device
US6210909B1 (en) 1991-04-18 2001-04-03 Lamina, Inc. Liquid specimen container and attachable testing modules
US5330464A (en) 1992-03-11 1994-07-19 Baxter International Inc. Reliable breakable closure mechanism
US5431811A (en) 1992-05-19 1995-07-11 Hospal Ag Artificial kidney with device for filtering dialysis liquid
US5632906A (en) 1992-06-30 1997-05-27 Terumo Kabushiki Kaisha Apparatus and method for transferring separated component in liquid from a flexible bag in a centrifugal container
US5417673A (en) 1993-01-13 1995-05-23 Medex, Inc. Whole blood sample needleless sample site
US5520193A (en) 1993-02-22 1996-05-28 Issei Suzuki Blood collecting needle with vein indicator
JPH0716219A (ja) 1993-06-30 1995-01-20 Yoshikiyo Amagi 血管留置カテーテルからの採血方法及びそれに使用する器具
US5360011A (en) 1993-07-13 1994-11-01 Mccallister Teresa D Blood sample collection
US5762633A (en) 1993-10-26 1998-06-09 Eastland Technology Australia Pty, Ltd. Syringe or like parenteral device
US5575777A (en) 1993-11-15 1996-11-19 Becton Dickinson And Company Retractable needle cannula insertion set with refinements to better control leakage, retraction speed and reuse
US5429610A (en) 1993-11-19 1995-07-04 Vaillancourt; Vincent L. Dual chamber syringe for collecting samples and blood collecting system
US5603700A (en) 1993-12-27 1997-02-18 Daneshvar; Yousef Suction and injection system
US5573510A (en) 1994-02-28 1996-11-12 Isaacson; Dennis R. Safety intravenous catheter assembly with automatically retractable needle
US5649912A (en) 1994-03-07 1997-07-22 Bioject, Inc. Ampule filling device
US5472605A (en) 1994-03-10 1995-12-05 Hemasure, Inc. Filtration device useable for removal of leukocytes and other blood components
US5485854A (en) 1994-04-12 1996-01-23 Smiths Industries Medical Systems, Inc. Safety blood collection tube holder and assembly therefor
US5450856A (en) 1994-04-25 1995-09-19 Norris; Wendal A. Phlebotomy needle attachable to a vacuum container with a vent to preclude blood flashback
US6306614B1 (en) 1994-06-08 2001-10-23 Sepsis, Inc. Measurement of analytes in whole blood
US5507299A (en) 1994-06-13 1996-04-16 Roland; Patricia D. Multi-vial blood collection system
US5439450A (en) 1994-07-18 1995-08-08 Becton, Dickinson And Company Method of delivering a blood sample to an evacuated receptacle
US5772608A (en) 1994-12-28 1998-06-30 The Research Foundation Of State University Of New York System for sampling arterial blood from a patient
US5871699A (en) 1995-01-10 1999-02-16 Ruggeri; Guido Apparatus and method for drawing liquid samples and dispensing them into a plurality of test tubes
US6057105A (en) 1995-03-17 2000-05-02 Ngi/Cancer Tech Company, Llc Detection of melanoma or breast metastasis with a multiple marker assay
US5865812A (en) 1995-09-27 1999-02-02 United States Surgical Corporation Fluid flow control apparatus for surgical cannulae
WO1997018845A1 (es) 1995-11-23 1997-05-29 Santiago Coca Perez Jeringa automatica, presurizada y precargada
US6106509A (en) 1996-02-08 2000-08-22 Loubser; Paul G. Closed circuit autologous sequestration reservoir system
US5911705A (en) 1996-04-04 1999-06-15 Becton Dickinson And Company One step catheter advancement automatic needle retraction system
US5749857A (en) 1996-04-25 1998-05-12 Cuppy; Michael J. Catheter system
US6001307A (en) 1996-04-26 1999-12-14 Kyoto Daiichi Kagaku Co., Ltd. Device for analyzing a sample
US5857983A (en) 1996-05-17 1999-01-12 Mercury Diagnostics, Inc. Methods and apparatus for sampling body fluid
US5980830A (en) 1996-05-20 1999-11-09 Sendx Medical, Inc. Portable modular blood analyzer with simplified fluid handling sequence
US5824001A (en) 1996-06-10 1998-10-20 Becton Dickinson And Company Radially vented flashback chamber and plug assembly
US6506182B2 (en) 1996-06-12 2003-01-14 Biolink Corporation Method for subcutaneous access to the vascular system of a patient
US5876926A (en) 1996-07-23 1999-03-02 Beecham; James E. Method, apparatus and system for verification of human medical data
US5691486A (en) 1996-07-30 1997-11-25 Bayer Corporation Apparatus and methods for selecting a variable number of test sample aliquots to mix with respective reagents
US20020002349A1 (en) 1996-10-11 2002-01-03 Transvascular, Inc. Systems and methods for delivering drugs to selected locations within the body
US6010633A (en) 1997-03-06 2000-01-04 Hemasure Inc. Method of preventing air from becoming entrapped within a filtration device
US6126643A (en) 1997-03-06 2000-10-03 Vaillancouert; Vincent L. Blood collecting syringe
US5922551A (en) 1997-03-20 1999-07-13 Accumetrics, Inc. Agglutrimetric platelet binding assays in blood
US5971956A (en) 1997-04-15 1999-10-26 Biosurgical Corporation Medical suctioning apparatus and methods of use
US5811658A (en) 1997-04-29 1998-09-22 Medtronic, Inc. Ultrasonic diversion of microair in blood
WO1999010829A1 (en) 1997-08-22 1999-03-04 Deka Products Limited Partnership Health care system and method for physician order entry
WO1999010830A1 (en) 1997-08-22 1999-03-04 Deka Products Limited Partnership Automated health care system
WO1999010029A1 (en) 1997-08-22 1999-03-04 Deka Products Limited Partnership System and method for intelligent admixture and delivery of medications
USD410081S (en) 1997-08-22 1999-05-18 Bridge Medical, Inc. Medication infusion device
US6325975B1 (en) 1997-08-27 2001-12-04 Arkray, Inc. Suction generating device and sample analysis apparatus using the same
WO1999013925A1 (fr) 1997-09-12 1999-03-25 Asahi Medical Co., Ltd. Unite de filtrage permettant d'extraire les leucocytes et mode d'utilisation
US6016712A (en) 1997-09-18 2000-01-25 Accumetrics Device for receiving and processing a sample
US5961472A (en) 1997-09-26 1999-10-05 Baxter International Inc. Closed, one-handed blood sampling system
US6224561B1 (en) 1997-09-26 2001-05-01 Edwards Lifesciences Corporation Closed one-handed blood sampling system
US20030040708A1 (en) 1998-01-16 2003-02-27 Tandem Medical, Inc. Medication delivery apparatus
US6146360A (en) 1998-01-16 2000-11-14 Tandem Medical, Inc. Medication delivery apparatus
US6328726B1 (en) 1998-01-16 2001-12-11 Terumo Kabushiki Kaisha Blood collecting apparatus and blood-collecting method using blood collecting apparatus
US6074366A (en) 1998-01-16 2000-06-13 Tandem Medical Inc. Medication delivery apparatus
US6416496B1 (en) 1998-01-16 2002-07-09 Tandem Medical, Inc. Medication delivery apparatus
US8540663B2 (en) 1998-02-24 2013-09-24 Navilyst Medical, Inc. High flow rate dialysis catheters and related methods
US6403381B1 (en) 1998-06-08 2002-06-11 University Of Vermont And State Agriculture College Inhibition of coagulation in blood and blood products
WO2000024313A1 (en) 1998-10-26 2000-05-04 Noble House Group Pty Ltd Sampling in blood collection
US6626884B1 (en) 1998-10-26 2003-09-30 Noble House Group Pty. Ltd. Sampling in blood collection
US6746420B1 (en) 1998-12-11 2004-06-08 Dean B. Prestidge Parenteral apparatus
US6733433B1 (en) 1998-12-24 2004-05-11 Biosafe S.A. Blood separation system particularly for concentrating hematopoietic stem cells
US6569117B1 (en) 1999-01-01 2003-05-27 Elcam+Plastic Cooperative Agriculture Association Ltd. Blood sampling/injecting valve
WO2000041624A1 (en) 1999-01-12 2000-07-20 Elcam Plastic Blood sampling device
US6648835B1 (en) 1999-02-24 2003-11-18 Teva Medical Ltd. Fluid sampling apparatus
US6364890B1 (en) 1999-03-08 2002-04-02 Agilent Technologies, Inc. Extraction and transportation of blood for analysis
US20010039058A1 (en) 1999-05-14 2001-11-08 Iheme Mordi I. Fluid transfer device
US6520948B1 (en) 1999-07-29 2003-02-18 Baxter International Inc. Sampling tube holder for blood sampling system
US20050148993A1 (en) 1999-07-29 2005-07-07 Jean-Marie Mathias Method and apparatus for blood sampling
US7044941B2 (en) 1999-07-29 2006-05-16 Baxter International Inc. Method and apparatus for collecting blood samples prior to a blood collection procedure
US6387086B2 (en) 1999-07-29 2002-05-14 Baxter International Inc. Blood processing set including an integrated blood sampling system
US7479131B2 (en) 1999-07-29 2009-01-20 Fenwal, Inc. Biological fluid sampling apparatus, assembly and method
WO2001008546A2 (en) 1999-07-29 2001-02-08 Baxter International Inc. Sampling tube holder for blood sampling system
DE29913417U1 (de) 1999-08-06 2000-12-28 Zierden, Peter, Dr., 40764 Langenfeld Vorrichtung zur Entnahme von Blut aus einem Blutgefäß
DE10038026A1 (de) 1999-08-06 2001-02-22 Zierden Peter Vorrichtung zur Entnahme von Blut aus einem Blutgefäß
US6482188B1 (en) 1999-10-01 2002-11-19 Mission Medical Devices, Inc. Nonvented needle-free injection valve
US20020193751A1 (en) 1999-10-12 2002-12-19 Felix Theeuwes Regulation of drug delivery through flow diversion
US20040054333A1 (en) 1999-10-12 2004-03-18 Felix Theeuwes Regulation of drug delivery through flow diversion
US6511439B1 (en) 1999-12-07 2003-01-28 Terumo Kabushiki Kaisha Blood-collecting device
US6692479B2 (en) 2000-02-14 2004-02-17 Teva Medical Ltd. Donor blood sampling system
US20030208151A1 (en) 2000-02-14 2003-11-06 Menachem Kraus Predonation blood sampling apparatus
US7087047B2 (en) 2000-02-14 2006-08-08 Teva Medical Ltd. Predonation blood sampling apparatus
US6945948B2 (en) 2000-03-09 2005-09-20 Gambro, Inc. Extra-corporeal dual stage blood processing method and apparatus
US6736783B2 (en) 2000-04-12 2004-05-18 Merck & Co., Inc. Automated blood sampling apparatus
US20020004647A1 (en) 2000-05-02 2002-01-10 Leong Alvin Tan Chee Flashback blood collection needle
US20020107469A1 (en) 2000-11-03 2002-08-08 Charles Bolan Apheresis methods and devices
US7306736B2 (en) 2000-12-08 2007-12-11 Nephros, Inc. Valve mechanism for infusion fluid systems
WO2002051520A1 (en) 2000-12-21 2002-07-04 Hemerus Medical, Llc Biological fluid filter
US20030013991A1 (en) 2001-01-23 2003-01-16 Stone Benjamin Curtis Method of body fluid specimen collection
US6913580B2 (en) 2001-01-23 2005-07-05 Benjamin Curtis Stone Method of body fluid specimen collection
US6665385B2 (en) 2001-04-23 2003-12-16 Cardionet, Inc. Medical monitoring system having multipath communications capability
US8290129B2 (en) 2001-04-23 2012-10-16 Cardionet, Inc. Medical monitoring system having multiple communications channels
US6664893B1 (en) 2001-04-23 2003-12-16 Cardionet, Inc. Method for controlling access to medical monitoring device service
US7130396B2 (en) 2001-04-23 2006-10-31 Cardionet, Inc. Medical monitoring system having multiple communications channels
US7002468B2 (en) 2001-04-23 2006-02-21 Cardionet, Inc. Controlling access to a medical monitoring system
US6860871B2 (en) 2001-04-30 2005-03-01 Injectimed, Inc. Needle tip guard for percutaneous entry needles
US20030105414A1 (en) 2001-05-02 2003-06-05 Bd Medical Products, Pte. Ltd. Flashback blood collection needle
US6638252B2 (en) 2001-05-25 2003-10-28 Becton Dickinson And Company Cantilever push tab for an intravenous medical device
US20020183651A1 (en) 2001-05-29 2002-12-05 Hyun Dongchul D. Blood drawing system
US6843775B2 (en) 2001-05-29 2005-01-18 Smiths Medical Asd, Inc. Blood drawing system
US20030069543A1 (en) 2001-07-10 2003-04-10 Carpenter Kenneth W. Sterile aspiration/reinjection systems
DE10134913A1 (de) 2001-07-18 2003-02-20 Hiberna Ag Vorrichtung und Verfahren zur Blutpräparation
WO2003008012A2 (de) 2001-07-18 2003-01-30 Hiberna Ag Vorrichtung und verfahren zur blutpräparation
US20030055381A1 (en) 2001-09-17 2003-03-20 Wilkinson Bradley M. Medical devices
US20040010228A1 (en) 2001-09-25 2004-01-15 Becton, Dickinson And Company Activation of dual blunting needle assembly
US7614857B2 (en) 2001-11-16 2009-11-10 Medinnovation Ag Medical pump device
US20100152681A1 (en) 2002-01-31 2010-06-17 Jean-Marie Mathias Irreversible flow control clamp
US6957107B2 (en) 2002-03-13 2005-10-18 Cardionet, Inc. Method and apparatus for monitoring and communicating with an implanted medical device
US7241281B2 (en) 2002-04-08 2007-07-10 Thermogenesis Corporation Blood component separation method and apparatus
US20050161112A1 (en) 2002-04-09 2005-07-28 Rudolf Ehwald Automatic sample collector
US7461671B2 (en) 2002-04-09 2008-12-09 Humboldt-Universitaet Zu Berlin Automatic sample collector
US20050240161A1 (en) 2002-05-02 2005-10-27 Becton, Dickinson And Company Needle assembly
US20040009542A1 (en) 2002-05-03 2004-01-15 Gambro, Inc. Apparatus and method for detecting bacteria in blood products
US6905483B2 (en) 2002-06-07 2005-06-14 Becton, Dickinson And Company Flashback device for venous specimen collection
US20050004524A1 (en) 2002-06-07 2005-01-06 Becton, Dickinson And Company Flashback device for venous specimen collection
US7052603B2 (en) 2002-06-14 2006-05-30 Scilog, Inc. Single-use manifold for automated, aseptic transfer of soulutions in bioprocessing applications
US7316662B2 (en) 2002-07-09 2008-01-08 Gambro Lundia Ab Infusion device for medical use
US7384416B2 (en) 2002-08-12 2008-06-10 Macopharma Device and method for irreversible closure of fluid communication in a container system
US20040054283A1 (en) 2002-08-28 2004-03-18 Scott Corey Apparatus for hematocrit determination and method for its use
DE10243129A1 (de) 2002-09-18 2004-04-01 Ritter Gmbh Mehrfachblutentnahmegerät für Kleintiere und ähnliche Anwendungen
US6695004B1 (en) 2002-12-16 2004-02-24 Alaris Medical Systems, Inc. Magnetic automatic stop valve
US20040127816A1 (en) 2002-12-30 2004-07-01 Adriano Braun Galvao Handheld blood collection device
US7141097B2 (en) 2003-01-15 2006-11-28 Filtertek Inc. Bacterial retentive, air venting, intravenous filter
US20040147855A1 (en) 2003-01-23 2004-07-29 Becton, Dickinson And Company Coupling device for blood collection assembly
US6979323B2 (en) 2003-02-07 2005-12-27 Aragon Medical Corporation Closed system catheterization assembly and related methods
US20070100250A1 (en) 2003-02-14 2007-05-03 The Charlotte-Mecklenburg Hospital Authority Device and method for collection of exhaled alveolar breath condensate
US7618407B2 (en) 2003-02-19 2009-11-17 Macopharma Bag system with device for associating sampling receptacles
US20060251622A1 (en) 2003-05-21 2006-11-09 Koji Suzuki Container for serum production and method of regenerative medicine using the same
JP2010189415A (ja) 2003-05-21 2010-09-02 Jms Co Ltd 分離器具
US7351228B2 (en) 2003-11-06 2008-04-01 Becton, Dickinson And Company Plunger rod for arterial blood collection syringes
CN1901955A (zh) 2003-11-21 2007-01-24 瓦索根爱尔兰有限公司 医疗材料处理系统
CN2907683Y (zh) 2003-11-21 2007-06-06 瓦索金爱尔兰有限公司 用于处理自体血液样品的系统
WO2005068011A1 (en) 2004-01-13 2005-07-28 Cell Center Cologne Gmbh An apparatus and a method for controlling a fluid of extracorporeal circulation systems
US7055401B2 (en) 2004-03-15 2006-06-06 Haemonetics Corporation Closed method and system for the sampling and testing of fluid
US20050199077A1 (en) 2004-03-15 2005-09-15 Prybella John R. Closed method and system for the sampling and testing of fluid
US20080086085A1 (en) 2004-05-03 2008-04-10 Leroy Brown Blood drawing device with flash detection
US20050245885A1 (en) 2004-05-03 2005-11-03 Leroy Brown Blood drawing device with flash detection
US20110306899A1 (en) 2004-05-03 2011-12-15 Clearview Patient Safety Technologies, Llc Blood drawing device with flash detection
US20100010372A1 (en) 2004-05-03 2010-01-14 Clearview Patient Safety Technologies, Llc Porous multiple sample sleeve and blood drawing device for flash detection
US20100094171A1 (en) 2004-06-02 2010-04-15 Becton, Dickinson And Company Blood collection set with venting mechanism
US20050273019A1 (en) 2004-06-02 2005-12-08 Becton, Dickinson And Company Blood collection set with venting mechanism
US7335188B2 (en) 2004-06-12 2008-02-26 Graf Christian D Lumbar puncture fluid collection device
US20050281713A1 (en) 2004-06-18 2005-12-22 Bioanalytical Systems, Inc. (An Indiana Company) System and method for sample collection
US7615033B2 (en) 2004-08-16 2009-11-10 Becton, Dickinson And Company Flashback blood collection needle
WO2006031500A2 (en) 2004-09-10 2006-03-23 Becton, Dickinson And Company Reconstituting infusion device
US7666166B1 (en) 2004-12-27 2010-02-23 Blivic, Llc Bloodless intravenous integrated catheter
US7314452B2 (en) 2005-01-10 2008-01-01 Edwards Lifesciences Corporation Self flushing luer activated blood sampling devices
US20090050213A1 (en) 2005-05-03 2009-02-26 Sartorius Stedim Biotech Gmbh Connector, Connector System and Use Thereof
US7648491B2 (en) 2005-05-13 2010-01-19 Bob Rogers Medical substance transfer system
US20060287639A1 (en) 2005-06-15 2006-12-21 Inviro Medical Devices Ltd. Safety fluid transfer cannula
US8349254B2 (en) 2005-07-08 2013-01-08 Terumo Kabushiki Kaisha Circuit for collecting blood component and apparatus for collecting blood component
US20070088279A1 (en) 2005-07-26 2007-04-19 Ming-Jeng Shue Intravenous catheter introducing device with a tubular outlet member
WO2007033319A1 (en) 2005-09-13 2007-03-22 Edwards Lifesciences Corporation Closed blood sampling system with isolated pressure monitoring
US7744573B2 (en) 2005-09-13 2010-06-29 Edwards Lifesciences Corporation Closed blood sampling system with isolated pressure monitoring
US20080254471A1 (en) 2005-10-13 2008-10-16 Alamo Scientific Apparatus and Method for Microbial and Forensic Sampling and Manipulation
US20070119508A1 (en) 2005-11-29 2007-05-31 West Richard L Fluid Flow Diversion Valve and Blood Collection System Employing Same
US20120035540A1 (en) 2006-04-12 2012-02-09 Searete Llc, A Limited Liability Corporation Of The State Of Delaware Event-based control of a lumen traveling device
US20070287948A1 (en) 2006-06-07 2007-12-13 Paul Sakiewicz Method and device for reversing lines in the procedure of hemodialysis
US8834650B2 (en) 2006-07-21 2014-09-16 Ivera Medical Corporation Medical implement cleaning device
US8206514B2 (en) 2006-07-21 2012-06-26 Ivera Medical Corporation Medical implement cleaning device
US7985302B2 (en) 2006-07-21 2011-07-26 Ivera Medical Corporation Medical implement cleaning device
US20120216360A1 (en) 2006-07-21 2012-08-30 Rogers Bobby E Medical Implement Cleaning Device
US8999073B2 (en) 2006-07-21 2015-04-07 Ivera Medical Corporation Medical implement cleaning device
US7780794B2 (en) 2006-07-21 2010-08-24 Ivera Medical Corporation Medical implement cleaning device
US20100057004A1 (en) 2006-10-05 2010-03-04 Becton, Dickinson And Company Extravascular System In-Line Venting
US20080108954A1 (en) 2006-11-02 2008-05-08 Jean-Marie Mathias Flow Controllers
US8377040B2 (en) 2006-11-06 2013-02-19 Becton, Dickinson And Company Extravascular system venting
US8876734B2 (en) 2006-12-18 2014-11-04 Magnolia Medical Technologies, Inc. Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination
US8337418B2 (en) 2006-12-18 2012-12-25 Magnolia Medical Technologies, Inc. Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination
US8647286B2 (en) 2006-12-18 2014-02-11 Magnolia Medical Technologies, Inc. Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination
US8231546B2 (en) 2006-12-18 2012-07-31 Magnolia Medical Technologies, Inc. Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination
US8197420B2 (en) 2006-12-18 2012-06-12 Magnolia Medical Technologies, Inc. Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination
US20080167577A1 (en) 2006-12-29 2008-07-10 Weilbacher Eugene E Vented phlebotomy needle with flashback chamber
US20080185056A1 (en) 2007-02-01 2008-08-07 Saint-Gobain Performance Plastics Corporation Connector assembly
US9259284B2 (en) 2007-02-12 2016-02-16 3M Innovative Properties Company Female Luer connector disinfecting cap
US20170143447A1 (en) 2007-02-12 2017-05-25 3M Innovative Properties Company Female luer connector disinfecting cap
WO2008101025A1 (en) 2007-02-15 2008-08-21 Edwards Lifesciences Corporation Disposable, closed blood sampling system for use in medical conduit line
CN101631498A (zh) 2007-02-15 2010-01-20 爱德华兹生命科学公司 在医疗管线内使用的一次性、封闭的血液采样系统
US20080319346A1 (en) 2007-03-07 2008-12-25 Becton, Dickinson And Company Safety Blood Collection Assembly With Indicator
US20100268118A1 (en) 2007-09-27 2010-10-21 Gerd Schweiger System for removal and infusion of body fluid, and method for its operation
US20090192447A1 (en) 2008-01-25 2009-07-30 Smiths Medical Asd, Inc. Gas vent valve assembly
US7766879B2 (en) 2008-03-07 2010-08-03 Becton, Dickinson And Company Flashback blood collection needle
US8795198B2 (en) 2008-03-07 2014-08-05 Becton, Dickinson And Company Flashback blood collection needle
US8603009B2 (en) 2008-03-07 2013-12-10 Becton, Dickinson And Company Flashback blood collection needle
US20090306601A1 (en) 2008-06-10 2009-12-10 Shaw Thomas J Fluid Flow Control Device with Retractable Cannula
US20100042048A1 (en) 2008-08-15 2010-02-18 Becton, Dickinson And Company Luer Integrated Air Venting System
US8070725B2 (en) 2008-08-15 2011-12-06 Becton, Dickinson And Company Luer integrated air venting system
US8382712B2 (en) 2009-02-09 2013-02-26 E-Wha Fresenius Kabi Inc. Filter device and liquid injection apparatus having the same
US8574203B2 (en) 2009-02-11 2013-11-05 Becton, Dickinson And Company Systems and methods for providing a flushable catheter assembly
US8412300B2 (en) 2009-02-12 2013-04-02 Becton, Dickinson And Company Arterial flashback confirmation chamber
US8523826B2 (en) 2009-02-13 2013-09-03 Cytyc Corporation Luer-type needle-free valve fitting with bypass
US8827958B2 (en) 2009-05-12 2014-09-09 Access Scientific, Llc Access device with valve
US20100306938A1 (en) 2009-06-01 2010-12-09 Ivera Medical Corporation Medical implement cleaning device with friction-based fitting
US8568371B2 (en) 2009-06-22 2013-10-29 Np Medical Inc. Medical valve with improved back-pressure sealing
US8383044B2 (en) 2009-07-09 2013-02-26 Becton, Dickinson And Company Blood sampling device
WO2011030282A1 (en) 2009-09-09 2011-03-17 Poly Medicure Limited Blood collection device
WO2011069145A2 (en) 2009-12-04 2011-06-09 Becton, Dickinson And Company Blood collection tube with separation barrier
US20120265128A1 (en) 2009-12-11 2012-10-18 Harm Kolln Continuously Conveying Infusion Pump
US20110232020A1 (en) 2010-03-26 2011-09-29 Ivera Medical Corporation Medical implement cleaning device with friction-based fitting and energy directors
US20120004619A1 (en) 2010-03-31 2012-01-05 Stephens John D Needle protective device
US8287499B2 (en) 2010-04-30 2012-10-16 Tyco Healthcare Group Lp Syringe and catheter set comprising same
US20140261558A1 (en) 2010-04-30 2014-09-18 Ivera Medical Corporation Female luer connector disinfecting cap
US9138572B2 (en) 2010-06-24 2015-09-22 Np Medical Inc. Medical valve with fluid volume alteration
WO2012012127A2 (en) 2010-06-30 2012-01-26 Hoyle John D Jr Dosage control syringe
US9895092B2 (en) 2010-07-15 2018-02-20 Becton, Dickinson And Company Vented blood sampling device
US9314201B2 (en) 2010-07-15 2016-04-19 Becton, Dickinson And Company Removable flash chamber
US20120216359A1 (en) 2011-02-18 2012-08-30 Ivera Medical Corporation Medical Implement Cleaning System
US20120265099A1 (en) 2011-04-12 2012-10-18 Goodnow Ii James E Systems and Methods for Managing Blood Donations
US20140066880A1 (en) 2011-06-22 2014-03-06 Crisi Medical Systems, Inc. Selectively Controlling Fluid Flow Through A Fluid Pathway
US20150000061A1 (en) 2011-07-19 2015-01-01 Ivera Medical Corporation Cleaning Device For Male End Of Intraveneous Set
US8832894B2 (en) 2011-07-19 2014-09-16 Ivera Medical Corporation Cleaning device for male end of intraveneous set
US8864684B2 (en) 2011-10-13 2014-10-21 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US9060725B2 (en) 2011-10-13 2015-06-23 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US8535241B2 (en) 2011-10-13 2013-09-17 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US20180160958A1 (en) 2012-03-07 2018-06-14 Poly Medicure Limited Blood collection device
US9022950B2 (en) 2012-05-30 2015-05-05 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
EP2854643A1 (en) 2012-05-30 2015-04-08 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US9022951B2 (en) 2012-05-30 2015-05-05 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US9060724B2 (en) 2012-05-30 2015-06-23 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US20140150832A1 (en) 2012-06-04 2014-06-05 Bobby E. Rogers Male medical implement cleaning device
US20130335195A1 (en) 2012-06-18 2013-12-19 Bobby E. Rogers Source and Destination Lighted Indicator for Medical Fluid Lines
US9204864B2 (en) 2012-08-01 2015-12-08 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US9149576B2 (en) 2012-10-11 2015-10-06 Magnolia Medical Technologies, Inc. Systems and methods for delivering a fluid to a patient with reduced contamination
US9155495B2 (en) 2012-11-30 2015-10-13 Magnolia Medical Technologies, Inc. Syringe-based fluid diversion mechanism for bodily fluid sampling
US20150342510A1 (en) 2012-12-04 2015-12-03 Magnolia Medical Technologies, Inc. Sterile bodily-fluid collection device and methods
US10251590B2 (en) 2012-12-04 2019-04-09 Magnolia Medical Technologies, Inc. Sterile bodily-fluid collection device and methods
US9855386B2 (en) 2012-12-31 2018-01-02 Medtg, Llc Infusion and blood collection device and method
US20140261581A1 (en) 2013-03-15 2014-09-18 Ivera Medical Corporation Medical Implement Cleaning Device
US20150018715A1 (en) 2013-03-19 2015-01-15 Juan Nepomuc Walterspiel Devices and Methods to Reduce Contamination of Fluid Collected from a Patient
US20170071519A1 (en) 2013-04-15 2017-03-16 Becton, Dickinson And Company Biological Fluid Collection Device and Biological Fluid Separation and Testing System
US20180093077A1 (en) 2014-04-18 2018-04-05 Becton, Dickinson And Company Multi-use blood control safety catheter assembly
US20150359473A1 (en) 2014-06-13 2015-12-17 Chad Garrett Catheter Insertion Device with Blood Analyzer
US20160174888A1 (en) 2014-08-01 2016-06-23 Tasso, Inc. Devices, systems and methods for gravity-enhanced microfluidic collection, handling and transferring of fluids
WO2016054252A1 (en) 2014-09-30 2016-04-07 Exosome Diagnostics, Inc. Apparatuses, methods, and systems for sample collection and dispersion
US20160361006A1 (en) 2015-06-12 2016-12-15 Magnolia Medical Technologies, Inc. Devices and methods for syringe-based fluid transfer for bodily-fluid sampling
US20160367177A1 (en) 2015-06-19 2016-12-22 Becton, Dickinson And Company Biological Fluid Collection Device
US9820682B2 (en) 2015-07-24 2017-11-21 Kurin, Inc. Blood sample optimization system and blood contaminant sequestration device and method
US20190159711A1 (en) 2015-07-24 2019-05-30 Kurin, Inc. Blood sample optimization system and blood contaminant sequestration device and method
US20170020428A1 (en) 2015-07-24 2017-01-26 Calliope Solutions, Inc. Blood sample optimization system and blood contaminant sequestration device and method
US10010282B2 (en) 2015-07-24 2018-07-03 Kurin, Inc. Blood sample optimization system and blood contaminant sequestration device and method
US10143412B2 (en) 2015-07-24 2018-12-04 Kurin, Inc. Blood sample optimization system and blood contaminant sequestration device and method
US20170020427A1 (en) 2015-07-24 2017-01-26 Calliope Solutions, Inc. Blood sample optimization system and blood contaminant sequestration device and method
WO2017041087A1 (en) 2015-09-03 2017-03-09 Bullington Gregory J Apparatus and methods for maintaining sterility of a specimen container
US9950084B2 (en) 2015-09-03 2018-04-24 Magnolia Medical Technologies, Inc. Apparatus and methods for maintaining sterility of a specimen container
US20170361019A1 (en) 2016-06-15 2017-12-21 Michael Hopkins Syringe systems and methods for multi-stage fluid delivery
US20180177445A1 (en) 2016-12-27 2018-06-28 Kurin, Inc. Blood sample optimization system and blood contaminant sequestration device and method
US20180271425A1 (en) 2017-02-10 2018-09-27 Kurin, Inc. Blood contaminant sequestration device with one-way air valve and air-permeable blood barrier with closure mechanism
US20200281514A1 (en) 2017-02-10 2020-09-10 Kurin, Inc. Blood contaminant sequestration device with passive fluid control junction
US20180353117A1 (en) 2017-06-09 2018-12-13 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US20190030293A1 (en) 2017-07-25 2019-01-31 Kurin, Inc. Needle assembly with needle safety shield
US20190175087A1 (en) 2017-12-07 2019-06-13 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US20190365303A1 (en) 2018-05-31 2019-12-05 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
WO2019232196A1 (en) 2018-05-31 2019-12-05 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US20200305780A1 (en) 2019-04-01 2020-10-01 Kurin, Inc. Non-venting bodily fluid sample optimization device and system

Non-Patent Citations (159)

* Cited by examiner, † Cited by third party
Title
"Leukotrap Filtration Systems for Whole Blood Derived Platelets: Leukotrap RC PL and Leukotrap PL Systems," 2005 Brochure, Pall Corporation, 2 pages.
Arkin, C. F. et al., "Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard," Fifth Edition, Clinical and Laboratory Standards Institute, vol. 23, No. 32 (2003), 52 pages.
Barnard, D. R. & Arthur, M. M., "Fibronectin (cold insoluble globulin) in the neonate," Clinical and Laboratory Observations, 102(3): 453-455 (1983).
Baxter, "IV Tubing and Access Devices" authored by and published by Baxter, dated Nov. 6, 2006, 105 pages.
BD Saf-T-Intima Closed IV Catheter System, Becton, Dickinson and Company, 2015 Brochure. Retrieved from the Internet (Sep. 11, 2019) <https://www.bd.com/en-us/offerings/capabilities/infusion-therapy/iv-catheters/bd-saf-tintima-closed-iv-catheter-system>, 2 pages.
BD Vacutainer Passive Shielding Blood Collection Needle Brochure; Becton Dickinson and Company (2005), 2 pages.
Brecher, M. E. et al., "Bacterial Contamination of Blood Components," Clinical Microbiology Reviews, 18(1):195-204 (2005).
Calam, R. R., "Recommended ‘Order of Draw’ for Collecting Blood Specimens Into Additive-Containing Tubes," Letter to the Editor, Clinical Chemistry, 28(6):1399 (1982).
Cartridge and Test Information, Abbott, Art: 714258-01O Rev. Date: Aug. 15, 2016, 6 pages.
Challiner, A. et al., Queen Alexandra Hospital, Portsmouth P06 3LY, "Venous/arterial blood management protection system," Correspondence, p. 169.
De Korte, D. et al., "Diversion of first blood volume results in a reduction of bacterial contamination for whole-blood collections," Vox Sanguinis, 83:13-16 (2002).
De Korte, D. et al., "Effects of skin disinfection method, deviation bag, and bacterial screening on clinical safety of platelet transfusions in the Netherlands," Transfusion, 46: 476-485 (2006).
Edwards Lifesciences, "Conservation. Safety. Simplicity. Edwards VAMP and VAMP Jr. Systems," 2002 Brochure. Retrieved from the Internet (Sep. 11, 2019) <https://www.medline.com/media/catalog/Docs/MKT/VAMPSYSTEMBROCHURE.PDF>, 4 pages.
Ernst, D. J. et al., "NCCLS simplifies the order of draw: a brief history," MLO, 26-27 (2004).
Examination Report for United Kingdom Application No. GB1805101.1, dated May 25, 2018, 8 pages.
Exhibit 10—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 9,855,001 vs Stopcock-Syringe NPL, Aug. 30, 2019, 85 pages.
Exhibit 11—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 9,855,001 vs Ziegler NPL, Aug. 30, 2019, 8 pages.
Exhibit 12—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,028,689 vs Barnard NPL, Aug. 30, 2019, 12 pages.
Exhibit 13—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,028,689 vs U.S. Pat. No. 6,626,884, Aug. 30, 2019, 29 pages.
Exhibit 14—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,028,689 vs U.S. Pat. Pub. No. 2005/161112, Aug. 30, 2019, 48 pages.
Exhibit 15—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,028,689 vs U.S. Pat. No. 4,673,386, Aug. 30, 2019, 44 pages.
Exhibit 16—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,028,689 vs U.S. Pat. No. 4,904,240, Aug. 30, 2019, 31 pages.
Exhibit 17—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,028,689 vs Leukotrap NPL, Aug. 30, 2019, 113 pages.
Exhibit 19—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,028,689 vs U.S. Pat. No. 4,106,497, Aug. 30, 2019, 38 pages.
Exhibit 1—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 9,855,001 vs Barnard NPL, Aug. 30, 2019, 8 pages.
Exhibit 20—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,028,689 vs Stopcock-Syringe NPL, Aug. 30, 2019, 268 pages.
Exhibit 21—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs U.S. Pat. No. 6,626,884, Aug. 30, 2019, 35 pages.
Exhibit 22—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs U.S. Pat. Pub. No. 2005/161112, Aug. 30, 2019, 46 pages.
Exhibit 23—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs U.S. Pat. No. 4,207,870, Aug. 30, 2019, 20 pages.
Exhibit 24—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs U.S. Pat. No. 6,506,182, Aug. 30, 2019, 15 pages.
Exhibit 25—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs U.S. Pat. No. 4,673,386, Aug. 30, 2019, 53 pages.
Exhibit 26—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs U.S. Pat. No. 4,904,240, Aug. 30, 2019, 39 pages.
Exhibit 27—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs Leukotrap NPL, Aug. 30, 2019, 115 pages.
Exhibit 29—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs U.S. Pat. No. 4,106,497, Aug. 30, 2019, 45 pages.
Exhibit 2—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 9,855,001 vs BD Needle NPL, Aug. 30, 2019, 7 pages.
Exhibit 30—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs Stopcock-Syringe NPL, Aug. 30, 2019, 246 pages.
Exhibit 31—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs U.S. Pat. No. 4,349,035, Aug. 30, 2019, 26 pages.
Exhibit 32—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,220,139 vs U.S. Pat. Pub. No. 2008/0145933A1, Aug. 30, 2019, 39 pages.
Exhibit 33—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,039,483 vs Barnard NPL, Aug. 30, 2019, 14 pages.
Exhibit 34—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,039,483 vs U.S. Pat. No. 6,626,884, Aug. 30, 2019, 22 pages.
Exhibit 35—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,039,483 vs U.S. Pat. Pub. No. 2005/161112, Aug. 30, 2019, 45 pages.
Exhibit 36—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,039,483 vs U.S. Pat. No. 4,673,386, Aug. 30, 2019, 47 pages.
Exhibit 37—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,039,483 vs U.S. Pat. No. 4,904,240, Aug. 30, 2019, 30 pages.
Exhibit 38—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,039,483 vs Leukotrap NPL, Aug. 30, 2019, 115 pages.
Exhibit 3—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 9,855,001 vs U.S. Pat. No. 6,626,884, Aug. 30, 2019, 11 pages.
Exhibit 40—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,039,483 vs U.S. Pat. No. 4,106,497, Aug. 30, 2019, 45 pages.
Exhibit 41—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,039,483 vs Stopcock-Syringe NPL, Aug. 30, 2019, 214 pages.
Exhibit 42—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 10,039,483 vs U.S. Pat. Pub. No. 2008/0145933A1, Aug. 30, 2019, 38 pages.
Exhibit 4—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 9,855,001 vs U.S. Pat. Pub. No. 2005/161112, Aug. 30, 2019, 22 pages.
Exhibit 5—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 9,855,001 vs U.S. Pat. No. 4,673,386, Aug. 30, 2019, 21 pages.
Exhibit 6—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 9,855,001 vs U.S. Pat. No. 4,904,240, Aug. 30, 2019, 15 pages.
Exhibit 7—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 9,855,001 vs Leukotrap NPL, Aug. 30, 2019, 38 pages.
Exhibit 9—Defendant's Invalidity Contentions, Invalidity Claim Chart—U.S. Pat. No. 9,855,001 vs U.S. Pat. No. 4,106,497, Aug. 30, 2019, 22 pages.
Extended European Search Report for EP Application No. 18188136.8, dated May 16, 2019, 9 pages.
Extended European Search Report for European Application No. 17204012.3, dated Feb. 14, 2018, 7 pages.
Extended European Search Report for European Application No. 17206745.6, dated Feb. 19, 2018.
Gottlieb, T., "Hazards of Bacterial Contamination of Blood Products," Anaesth Intens Care, 21: 20-23 (1993).
Hall, K. K. et al., "Updated Review of Blood Culture Contamination," Clinical Microbiology Reviews, 19(4):788-802 (2006).
Hillyer, C. D. et al., "Bacterial Contamination of Blood Components Risks, Strategies, and Regulation," Hematology, 575-589 (2003).
International Search Report and Written Opinion dated Aug. 22, 2019 for International Application No. PCT/US2019/034626, 16 pages.
International Search Report and Written Opinion for International Application No. PCT/US2007/087951 dated May 16, 2008, 8 pages.
International Search Report and Written Opinion for International Application No. PCT/US2013/043289, dated Oct. 24, 2013, 15 pages.
International Search Report and Written Opinion for International Application No. PCT/US2013/052493, dated Nov. 27, 2013, 7 pages.
International Search Report and Written Opinion for International Application No. PCT/US2013/063975, dated Mar. 20, 2014, 16 pages.
International Search Report and Written Opinion for International Application No. PCT/US2013/071491, dated Aug. 5, 2014, 9 pages.
International Search Report and Written Opinion for International Application No. PCT/US2013/073080, dated Feb. 18, 2014, 14 pages.
International Search Report and Written Opinion for International Application No. PCT/US2016/050380, dated Dec. 1, 2016, 6 pages.
International Search Report and Written Opinion for International Application No. PCT/US2018/050621, dated Nov. 26, 2018, 11 pages.
International Search Report and Written Opinion for International Application No. PCT/US2018/064561, dated Feb. 11, 2019, 9 pages.
International Search Report and Written Opinion for International Application No. PCT/US2018/36910, dated Sep. 4, 2018, 13 pages.
International Search Report and Written Opinion for International Application No. PCT/US2020/022125, dated May 26, 2020, 17 pages.
Kim, J. Y. et al., "The Sum of the Parts is Greater Than the Whole: Reducing Blood Culture Contamination," Annals of Internal Medicine, 154:202-203 (2011).
Levin, P. D. et al., "Use of the Nonwire Central Line Hub to Reduce Blood Culture Contamination," Chest, 143(3):640-645 (2013).
Li, Y. et al., "Direct labeling and visualization of blood vessels with lipophilic carbocyanine dye Dil," Nature Protocols, 3(11): 1703-1708 (2008).
Liumbruno, G. M. et al., "Reduction of the risk of bacterial contamination of blood components through diversion of the first part of the donation of blood and blood components," Blood Transfus, 7: 86-93 (2009).
Mayer, G. A., "A Method for the Reliable Determination of Clotting Time in Whole Blood," Can Med Assoc J., 72(12): 927-929 (1955).
McDonald, C. P., "Interventions Implemented to Reduce the Risk of Transmission of Bacteria by Transfusion in the English National Blood Service," Transfus Med Hemother, 38:255-258 (2011).
Meissner, G. F. et al., "A Method Based on the Use of Whole Venous Blood in Capillary Tubes," American Journal of Clinical Pathology, 33(2): 29-31 (1963).
Murphy, M., "Better Blood Transfusion," Journal of the Intensive Core Society, 4(3): 78-80 (2003).
Napolitano, M. et al., "Quality control of bacterial contamination of blood components: the feasibility of diversion system testing," Blood Transfus, 2: 231-232 (2004).
Norberg, A. et al., "Contamination Rates of Blood Cultures Obtained by Dedicated Phlebotomy vs Intravenous Catheter," JAMA, 289(6): 726-729 (2003).
Notice of Reasons for Rejection for Japanese Application No. 2015-545813, dated Jul. 4, 2017, 14 pages.
Notice of Reasons for Rejection for Japanese Application No. 2018-081980, dated Feb. 21, 2019, 9 pages.
Notice of Reasons for Rejection for Japanese Application No. 2018-086721, dated Mar. 15, 2019, 6 pages.
Notice of Reasons for Rejection for Japanese Application No. 2019-230734, dated Jan. 22, 2021, 9 pages.
Notification of the First Office Action for Chinese Application No. 201380040468.7, dated Jun. 30, 2016, 9 pages.
Notification of the First Office Action for Chinese Application No. 201380072185.0, with English translation, dated Sep. 28, 2016, 17 pages.
Office Action for Chinese Application No. 201711078173.5, dated Feb. 3, 2020, with English translation, 14 pages.
Office Action for U.S. Appl. No. 11/955,635, dated Dec. 3, 2010, 11 pages.
Office Action for U.S. Appl. No. 11/955,635, dated Jul. 22, 2010, 11 pages.
Office Action for U.S. Appl. No. 13/335,241, dated Apr. 20, 2012, 12 pages.
Office Action for U.S. Appl. No. 13/458,508, dated Jul. 24, 2012, 13 pages.
Office Action for U.S. Appl. No. 13/675,295, dated May 23, 2013, 15 pages.
Office Action for U.S. Appl. No. 13/952,964, dated Mar. 20, 2015, 11 pages.
Office Action for U.S. Appl. No. 13/954,528, dated Mar. 17, 2014, 10 pages.
Office Action for U.S. Appl. No. 14/049,326, dated Apr. 24, 2015, 10 pages.
Office Action for U.S. Appl. No. 14/089,267, dated Jun. 19, 2014, 13 pages.
Office Action for U.S. Appl. No. 14/096,826, dated Jul. 26, 2017, 12 pages.
Office Action for U.S. Appl. No. 14/096,826, dated Mar. 8, 2018, 14 pages.
Office Action for U.S. Appl. No. 14/493,796, dated Jan. 27, 2015, 7 pages.
Office Action for U.S. Appl. No. 14/494,208, dated Jan. 27, 2015, 7 pages.
Office Action for U.S. Appl. No. 14/498,102, dated Oct. 17, 2017, 20 pages.
Office Action for U.S. Appl. No. 14/498,102, dated Sep. 24, 2018, 18 pages.
Office Action for U.S. Appl. No. 14/662,676, dated Sep. 5, 2018, 25 pages.
Office Action for U.S. Appl. No. 14/712,437 dated Oct. 25, 2018, 20 pages.
Office Action for U.S. Appl. No. 14/728,318, dated Dec. 20, 2018, 26 pages.
Office Action for U.S. Appl. No. 14/728,318, dated Jan. 8, 2018, 36 pages.
Office Action for U.S. Appl. No. 14/728,318, dated May 19, 2017, 26 pages.
Office Action for U.S. Appl. No. 14/838,794, dated Aug. 3, 2017, 7 pages.
Office Action for U.S. Appl. No. 14/880,397, dated Apr. 17, 2018, 6 pages.
Office Action for U.S. Appl. No. 14/880,397, dated Sep. 24, 2018, 5 pages.
Office Action for U.S. Appl. No. 14/926,784, dated Jan. 15, 2019, 15 pages.
Office Action for U.S. Appl. No. 14/926,784, dated Jan. 21, 2020, 17 pages.
Office Action for U.S. Appl. No. 14/926,784, dated May 25, 2018, 15 pages.
Office Action for U.S. Appl. No. 15/088,842, dated Nov. 23, 2016, 20 pages.
Office Action for U.S. Appl. No. 15/432,310, dated Apr. 12, 2017, 14 pages.
Office Action for U.S. Appl. No. 15/435,684, dated Jun. 12, 2017, 28 pages.
Office Action for U.S. Appl. No. 15/448,891, dated Jun. 16, 2017, 34 pages.
Office Action for U.S. Appl. No. 15/457,082, dated Jun. 15, 2017, 22 pages.
Office Action for U.S. Appl. No. 15/829,015, dated Feb. 6, 2018, 24 pages.
Office Action for U.S. Appl. No. 15/829,018, dated Feb. 16, 2018, 24 pages.
Office Action for U.S. Appl. No. 15/829,023, dated Feb. 7, 2018, 25 pages.
Office Action for U.S. Appl. No. 15/832,055, dated Feb. 8, 2018, 21 pages.
Office Action for U.S. Appl. No. 15/832,087, dated Feb. 7, 2018, 24 pages.
Office Action for U.S. Appl. No. 15/832,091, dated Feb. 22, 2018, 16 pages.
Office Action for U.S. Appl. No. 15/854,273, dated Jan. 13, 2020, 13 pages.
Office Action for U.S. Appl. No. 15/854,273, dated Sep. 7, 2018, 15 pages.
Office Action for U.S. Appl. No. 15/925,159, dated May 14, 2019, 15 pages.
Office Action for U.S. Appl. No. 15/925,159, dated Nov. 26, 2018, 11 pages.
Office Action for U.S. Appl. No. 16/255,055, dated Mar. 18, 2019, 16 pages.
Office Action for U.S. Appl. No. 16/274,835, dated Feb. 12, 2021, 17 pages.
Office Action for U.S. Appl. No. 16/299,962, dated Dec. 9, 2020, 15 pages.
Office Action for U.S. Appl. No. 16/299,962, dated May 2, 2019, 14 pages.
Order of Draw for Multiple Tube Collections, LabNotes, a newsletter from BD Diagnostics,—Preanalytical Systems, 17(1):3 (2007).
Page, C. et al., "Blood conservation devices in critical care: a narrative review," Annals of Intensive Care, 3:14 (2013), 6 pages.
Palavecino, E. L. et al., "Detecting Bacterial Contamination in Platelet Products," Clin. Lab., 52:443-456 (2006).
Patel, R. et al., "Optimized Pathogen Detection with 30- Compared to 20-Milliliter Blood Culture Draws." Journal of Clinical Microbiology, 49(12):4047-4051 (2011).
Patton, R. G. et al., "Innovation for Reducing Blood Culture Contamination: Initial Specimen Diversion Technique," Journal of Clinical Microbiology, 48(12):4501-4503 (2010).
Perez, P. et al., "Multivariate analysis of determinants of bacterial contamination of whole-blood donations," Vox Sanguinis, 82:55-60 (2002).
Proehl, J. A. et al., "Clinical Practice Guideline: Prevention of Blood Culture Contamination, Full Version," 2012 ENA Emergency Nurses Resources Development Committee, Emergency Nurses Association (Dec. 2012), 14 pages.
Quilici, N. et al., "Differential Quantitative Blood Cultures in the Diagnosis of Catheter-Related Sepsis in Intensive Care Units," Clinical Infectious Diseases 25:1066-1070 (1997).
Schuur, J., "Blood Cultures: When Do they Help and When Do They Harm?" Brigham & Women's Hospital, Department of Emergency Medicine, (Jun. 21-23, 2012), 42 pages.
Sheppard, C. A. et al., "Bacterial Contamination of Platelets for Transfusion: Recent Advances and Issues," LabMedicine, 36(12):767-770 (2005).
Shulman, G., "Quality of Processed Blood for Autotransfusion," The Journal of Extra-Corporeal Technology, 32(1):11-19 (2000).
Sibley, C. D. et al., "Molecular Methods for Pathogen and Microbial Community Detection and Characterization: Current and Potential Application in Diagnostic Microbiology," Infection, Genetics and Evolution 12:505-521 (2012).
Stohl, S. et al., "Blood Cultures at Central Line Insertion in the Intensive Care Unit: Comparison with Peripheral Venipuncture," Journal of Clinical Microbiology, 49(7):2398-2403 (2011).
Supplementary European Search Report for European Application No. 13797732.8, dated Dec. 7, 2015, 5 pages.
Supplementary European Search Report for European Application No. 13845555.5, dated Jul. 12, 2016, 9 pages.
Supplementary European Search Report for European Application No. 13860741.1, dated Jun. 7, 2016, 5 pages.
Tang, M. et al., "Closed Blood Conservation Device for Reducing Catheter-Related Infections in Children After Cardiac Surgery," Critical Care Nurse, 34(5): 53-61 (2014).
Wagner et al., "Diversion of Initial Blood Flow to Prevent Whole-Blood Contamination by Skin Surface Bacteria: an in vitro model," Transfusion, 40:335-338 (2000).
Wang, P. et al., "Strategies on Reducing Blood Culture Contamination," Reviews in Medical Microbiology, 23:63-66 (2012).
Weinbaum, F. I. et al., "Doing It Right the First Time: Quality Improvement and the Contaminant Blood Culture," Journal of Clinical Microbiology, 35(3): 563-565 (1997).
Weinstein, M. P. et al., "The Clinical Significance of Positive Blood Cultures in the 1990s: A Prospective Comprehensive Evaluation of the Microbiology, Epidemiology, and Outcome of Bacteremia and Fungemia in Adults," Clinical Infectious Diseases, 24:584-602 (1997).
Weinstein, M. P., "Current Blood Culture Methods and Systems: Clinical Concepts, Technology, and Interpretation of Results," Clinical Infectious Diseases, 23: 40-46 (1996).
Weinstein, M. P., "Minireview: Blood Culture Contamination: Persisting Problems and Partial Progress," Journal of Clinical Microbiology, 41(6): 2275-2278 (2003).
Ziegler, et al., "Controlled Clinical Laboratory Comparison of Two Supplemented Aerobic and Anaerobic Media Used in Automated Blood Culture Systems to Detect Bloodstream Infections," J. Clinical Microbiology, 36(3):657-661 (1998).
Zimmon, D. S. et al., "Effect of Portal Venous Blood Flow Diversion on Portal Pressure," J Clin Invest, 65(6): 1388-1397 (1980).
Zundert, A. V., "New Closed IV Catheter System," Acta Anaesth. Belg., 56: 283-285 (2005).

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11998332B2 (en) 2012-05-30 2024-06-04 Magnolia Medical Technologies, Inc. Fluid diversion mechanism for bodily-fluid sampling
US11890452B2 (en) 2012-10-11 2024-02-06 Magnolia Medical Technologies, Inc. Systems and methods for delivering a fluid to a patient with reduced contamination
US12083234B2 (en) 2015-09-03 2024-09-10 Magnolia Medical Technologies, Inc. Apparatus and methods for maintaining sterility of a specimen container
US11653863B2 (en) 2017-09-12 2023-05-23 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US11529081B2 (en) 2017-09-12 2022-12-20 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US11903709B2 (en) 2017-09-12 2024-02-20 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US11903710B2 (en) 2017-09-12 2024-02-20 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US11419531B2 (en) 2017-12-07 2022-08-23 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
US11883170B2 (en) * 2018-05-01 2024-01-30 Becton, Dickinson And Company Biological fluid micro-sample management device
US20210267512A1 (en) * 2018-05-01 2021-09-02 Becton, Dickinson And Company Biological Fluid Micro-Sample Management Device
US20210161448A1 (en) * 2018-06-07 2021-06-03 Becton, Dickinson And Company Biological fluid separation device
US12076146B2 (en) * 2018-06-07 2024-09-03 Becton, Dickinson And Company Biological fluid separation device
US11786155B2 (en) 2019-02-08 2023-10-17 Magnolia Medical Technologies, Inc. Devices and methods for bodily fluid collection and distribution
US11857321B2 (en) 2019-03-11 2024-01-02 Magnolia Medical Technologies, Inc. Fluid control devices and methods of using the same
WO2023230520A1 (en) 2022-05-24 2023-11-30 Magnolia Medical Technologies, Inc. Fluid transfer devices with integrated flow-based assay and methods of using the same for identifying sepsis
US12133968B2 (en) 2023-12-28 2024-11-05 Magnolia Medical Technologies, Inc. Systems and methods for delivering a fluid to a patient with reduced contamination

Also Published As

Publication number Publication date
WO2019055487A1 (en) 2019-03-21
US20220175284A1 (en) 2022-06-09
EP3681384A4 (en) 2021-09-01
EP4205640A1 (en) 2023-07-05
EP3681384A1 (en) 2020-07-22
IL313917A (en) 2024-08-01
EP3681384B1 (en) 2022-12-28
US11529081B2 (en) 2022-12-20
CN111212597A (zh) 2020-05-29
AU2018334138A1 (en) 2020-03-12
US20190076074A1 (en) 2019-03-14
AU2024205062A1 (en) 2024-08-15
US20220369972A1 (en) 2022-11-24
US20220369970A1 (en) 2022-11-24
CN111212597B (zh) 2023-04-11
ES2939951T3 (es) 2023-04-28
US20230248281A1 (en) 2023-08-10
US20230240571A1 (en) 2023-08-03
US20240315624A1 (en) 2024-09-26
CA3074105A1 (en) 2019-03-21
JP7204742B2 (ja) 2023-01-16
US20240315621A1 (en) 2024-09-26
US11903709B2 (en) 2024-02-20
US20240315620A1 (en) 2024-09-26
US11653863B2 (en) 2023-05-23
JP2020533045A (ja) 2020-11-19
AU2018334138B2 (en) 2024-05-23
US20240315622A1 (en) 2024-09-26
IL273025B1 (en) 2024-08-01
US20240138734A1 (en) 2024-05-02
US20240315623A1 (en) 2024-09-26
IL273025A (en) 2020-04-30
CN116250868A (zh) 2023-06-13
US11903710B2 (en) 2024-02-20
JP2023052175A (ja) 2023-04-11

Similar Documents

Publication Publication Date Title
US11903709B2 (en) Fluid control devices and methods of using the same
US20230190157A1 (en) Fluid control devices and methods of using the same
EP4101380B1 (en) Fluid control devices
US11857321B2 (en) Fluid control devices and methods of using the same
JP7579321B2 (ja) 血液制御デバイス

Legal Events

Date Code Title Description
FEPP Fee payment procedure

Free format text: ENTITY STATUS SET TO UNDISCOUNTED (ORIGINAL EVENT CODE: BIG.); ENTITY STATUS OF PATENT OWNER: SMALL ENTITY

FEPP Fee payment procedure

Free format text: ENTITY STATUS SET TO SMALL (ORIGINAL EVENT CODE: SMAL); ENTITY STATUS OF PATENT OWNER: SMALL ENTITY

STPP Information on status: patent application and granting procedure in general

Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION

STPP Information on status: patent application and granting procedure in general

Free format text: NON FINAL ACTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: NON FINAL ACTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER

AS Assignment

Owner name: MAGNOLIA MEDICAL TECHNOLOGIES, INC., WASHINGTON

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BULLINGTON, GREGORY J.;MIAZGA, JAY M.;GAW, SHAN E.;AND OTHERS;SIGNING DATES FROM 20200330 TO 20200509;REEL/FRAME:055602/0646

STPP Information on status: patent application and granting procedure in general

Free format text: NOTICE OF ALLOWANCE MAILED -- APPLICATION RECEIVED IN OFFICE OF PUBLICATIONS

AS Assignment

Owner name: FISH & RICHARDSON P.C., MINNESOTA

Free format text: LIEN;ASSIGNOR:MAGNOLIA MEDICAL TECHNOLOGIES, INC.;REEL/FRAME:057204/0676

Effective date: 20210318

STPP Information on status: patent application and granting procedure in general

Free format text: PUBLICATIONS -- ISSUE FEE PAYMENT RECEIVED

STPP Information on status: patent application and granting procedure in general

Free format text: PUBLICATIONS -- ISSUE FEE PAYMENT VERIFIED

STCF Information on status: patent grant

Free format text: PATENTED CASE

AS Assignment

Owner name: MAGNOLIA MEDICAL TECHNOLOGIES, INC, WASHINGTON

Free format text: RELEASE BY SECURED PARTY;ASSIGNOR:FISH & RICHARDSON PC;REEL/FRAME:058964/0845

Effective date: 20211214

AS Assignment

Owner name: SYMBIOTIC CAPITAL AGENCY LLC, AS ADMINISTRATIVE AGENT, CALIFORNIA

Free format text: PATENT SECURITY AGREEMENT;ASSIGNOR:MAGNOLIA MEDICAL TECHNOLOGIES, INC.;REEL/FRAME:066178/0969

Effective date: 20231229